LEXINGTON A Central Kentucky cardiothoracic and vascular surgeon will be the first in Kentucky to provide a minimally invasive graft for the treatment of previously inoperable abdominal aortic aneurysms (AAA). Dermot Halpin, MD, FACS, of Surgical Associates of Lexington, has been selected by Cook Medical of Bloomington, IN to be one of 50 surgeons nationwide – and the first in Kentucky – to insert the fenestrated endovascular graft for complex abdominal aneurysm repairs. FDA approval for the device, called the Zenith Flex AAA Endovascular Graft, is projected for spring of 2012.
According to Halpin, most patients who present with juxtarenal and suprarenal AAA’s are turned away because the complications from open abdominal surgery are too great. Elderly with pulmonary distress and coronary artery disease, these patients are poor candidates for open abdominal surgery. Furthermore, aneurysms juxtaposed or above the renal arteries make traditional stents un-useable.
Cook Medical’s Zenith Fenestrated Flex Graft will allow the surgeon to stent abdominal aortic aneurysms, at or near the renal arteries through a minimally invasive technique. “This is groundbreaking surgery in complex abdominal aortic aneurysm treatment,” says Halpin, who first became aware of the new technology after hearing about it from an Australian cardiovascular surgeon at a CME event in 2010.
Halpin then traveled to Australia to see the device in use. Accompanied by surgeons from Florida, Arkansas, and Ohio, including Roy C. Greenberg, MD, director of endovascular research at the Cleveland Clinic, the surgeons observed live and telesurgery implantations of the device. They also toured the Cook Medical plant in Brisbane, gaining hands on bench experience with implantations and observed the meticulous construction techniques used in customizing each graft from CT scans. That is when Halpin decided, “This is a technology we need in Kentucky and in the US.”
Now, patients who require AAA repair can avoid the lengthy hospital stays, months of recuperation, renal failure and subsequent kidney dialysis that marred the open surgical approach.
Each Zenith Fenestrated Flex Graft is custom made for the individual patient’s anatomy allowing for the specific location and orientation of left and right renal arteries. The graft requires precise placement by the surgeon who must align the renal arterial ports, which is achieved by pre-surgical CT mapping and angiography of the site.
Zenith Fenestrated Flex Grafts must be implanted in a hybrid radiology surgical suite such as the one at Saint Joseph Hospital in Lexington where Halpin has assembled his expert surgical team. “The 3D imaging is absolutely necessary to align the openings in the fenestrated graft to the renal arteries,” emphasizes Halpin. “We must be within millimeters to be successful.” Since urging SJH administration to commit to the hybrid surgical suite five years ago, Halpin and his hybrid surgical team have performed hundreds of successful complex abdominal aortic surgeries.
According to information provided by the manufacturer, a clinical study of 280 patients in the US compared patients treated with the Zenith AAA Endovascular Graft to patients with open abdominal surgery with highly favorable results. As in most minimally invasive surgeries there was less blood loss, less trauma, shorter hospital stays and quicker returns to normal pre-operative function by the patients with the new graft.
Post operative surveillance is a key component of the treatment, says Halpin. Although rare, there is potential for graft migration, so a follow-up CT scan after 6 months is required. Complications in the clinical study were less than 2%.
Aortic Center for Excellence
Surgeons interested in using the Zenith Flex Fenestrated graft will face several challenges. First is the extensive pre-op planning for the design and construction of the custom graft. Second is the precision CT guided surgery technique needed to insert the graft then align and connect the arterial ports. Third is the post op surveillance regimen. To deal with these challenges, Halpin is creating an Aortic Center of Excellence (ACE) in Kentucky.
As medical director of the ACE, Halpin is developing protocols for the continued training of cardiothoracic and vascular surgeons in complex aortic pathology including abdominal aneurysms, pararenal and juxtarenal aneurysms, thoracoabdominal aneurysm and percutaneous aortic valve.
The FDA will monitor the deployment of the Zenith Flex Fenestrated Graft at selected surgical sites. Through ACE, Halpin plans to have his surgical team at Saint Joseph Hospital participate in the FDA introductory training process so they can aid in the training of teams in other states. “The planning and insertion of the fenestrated grafts exceeds the skill level of most cardiothoracic surgeons without additional training,” he says.
By creating what Halpin calls “a superior care center for aortic patients,” ACE’s highly trained surgical team will focus on the treatment of aortic disorders. “I know the need is there and patients will be far better served.”
Surgeons interested in using the Zenith Flex Fenestrated Graft will face several challenges. To deal with these challenges, Halpin is creating an Aortic Center of Excellence in Kentucky.