When noted cardiac surgeon Simon Maltais, MD, PhD, FRCSC arrived in Nashville in July 2011 to lead the Heart Transplantation and Ventricular Assist Device (VAD) programs for Vanderbilt Heart & Vascular Institute (VHVI), he was given a mandate … to grow Vanderbilt into one of the top-ranked programs in the nation.
Since then, the team has garnered national accolades, but it doesn’t mean they see their work as ‘mission accomplished.’ Instead, Maltais and colleagues are focused on continued program growth, research expansion, and setting new benchmarks in outcomes and patient satisfaction.
Some of Vanderbilt’s growth in transplantation was a natural byproduct of the Saint Thomas Health decision to discontinue the city’s oldest heart transplant program in January 2012 in order to concentrate on a new VAD Center with a focus on destination therapy. But that doesn’t tell the whole story.
Although Saint Thomas was responsible for approximately 350 heart transplants since performing the state’s first one in 1985, volumes had been on the decline in recent years with only eight such surgeries in 2010 and 10 heart transplants in 2011, according to the Organ Procurement and Transplantation Network. By then, Vanderbilt’s numbers were already climbing. In 2013, Vanderbilt hit new heights in terms of volume.
“This last year, we had our busiest year ever with over 40 heart transplants,” said Maltais. “That’s putting us in the top 10 programs in the country for heart transplantation.”
Although volume is an important marker, it’s the survival rates that have really set Vanderbilt’s program apart. “There are only two programs in the U.S. with 100 percent survival rate at one year … Vanderbilt and the Cleveland Clinic,” said Maltais, a native of Canada who came to VHVI by way of the Mayo Clinic.
Like Saint Thomas, Vanderbilt also has a dedicated VAD center, which has taken an active role in device trials over the past decade. The VHVI program became certified for destination therapy in 2012. Previously, Vanderbilt implanted VADs as a bridge therapy to heart transplantation.
The volume of LVAD implants, however, has really soared since Maltais arrived. From 2009-2011, Vanderbilt performed 12 LVAD implants (with nine coming in 2011). By 2012, that number had increased to 33. Last year, Vanderbilt’s LVAD program hit a major milestone. On July 30, 2013, patient William Whitwell became the 100th patient to receive a VAD implant at Vanderbilt. Maltais noted the growth in the VAD program has put Vanderbilt among the top five in the nation with more than 80 long-term implants in 2013.
Last year also saw the introduction of the new HeartWare ventricular assistance system (VAS) for bridge implants. VHVI became the first program in Tennessee to implant the miniaturized circulatory support device in January 2013, following HeartWare’s FDA approval the previous November. By year’s end, Vanderbilt ranked first in the nation for the number of HeartWare device systems implanted in patients with end-stage heart failure bridged to transplantation.
“It can be used in a larger population because it can be implanted with different strategies or with different implant configurations,” explained Maltais, noting HeartWare also provides the team with more options for patients with congenital heart disease. The pump, he continued, doesn’t need a pocket. “It’s completely within the pericardium. We have much more versatility for patients with small habitus,” he added.
As for the outflow portion of the device, Maltais said it is much easier to implant at different arterial sites. “With our new minimally invasive … sometimes off-pump … HeartWare implant approaches, we avoid a full sternotomy. We don’t have to split the breastbone open,” he continued.
According to Maltais, the small size and minimally invasive surgical requirements make HeartWare easier to implant and decrease the risk of perioperative bleeding and infection. At present, HeartWare is only approved for bridge therapy. However, Maltais said it is highly effective, allowing patients to remain on the support system for as long as needed. In fact, he anticipates a change in the HeartWare approval status pending completion of current trial evaluation. “Hopefully a year from now, the indication will expand to destination therapy.”
Although Vanderbilt employs several devices in the acute setting, Maltais said the team depends on the HeartMate II and HeartWare devices for long-term implantation to achieve haemodynamic stabilization. “The technology is better. The risk of complication has gone down dramatically with those two devices,” he noted.
With the increases in transplant and VAD volumes has come significant growth in staff. Maltais said three years ago, the VAD program had one coordinator. “We have a very large team now in our LVAD Center. We have four VAD coordinators plus dedicated ancillary staff,” he noted, adding the integrated clinical team includes pharmacists, nutritionists and social workers in addition to physicians and nurses.
“With Dr. Mary E. Keebler as the medical director of our LVAD program, we have four advanced heart failure cardiologists and just hired two (more). By July 2014, we’ll be at six cardiologists that are focused on LVAD and transplant,” he said. In addition, the team has just hired another surgeon who will join Maltais at the beginning of April.
The increased manpower and resources undoubtedly will be put to good use as more than five million Americans suffer from heart failure with nearly 5 percent of them facing end-stage disease.