From left: Rami O. Tadros, MD, FACS; James F. McKinsey, MD, FACS; and Michael L. Marin, MD, FACS, are using a new-generation implantable device to treat complex thoracoabdominal aortic aneurysms.
Physicians at The Mount Sinai Hospital were among the first in the nation to implant an investigational device, a fabric and metal mesh tube known as a stent graft, as part of a clinical trial to treat aneurysms located in the thoracic/abdominal area of the aorta. Mount Sinai is one of only six institutions in the nation granted approval by the U.S. Food and Drug Administration to test the safety and initial feasibility of the device in patients.
The stent graft is used to strengthen the inner lining of the aorta—the main artery that carries blood from the heart to organs—in patients where the aortic walls have weakened and caused a balloon-type bulge known as an aneurysm to grow. Once implanted, the device serves to direct blood flow away from the aneurysm, causing it to shrink in size. If not repaired, the aneurysm can rupture and result in life-threatening internal bleeding.
“This is an important advance. We are the first in the region to implant this device and we were instrumental in its development,” says Michael L. Marin, MD, FACS, The Jacobson Professor of Surgery, and Chairman, Department of Surgery, Icahn School of Medicine at Mount Sinai, and Surgeon-in-Chief, Mount Sinai Health System. The minimally invasive procedure is being performed in several dozen select patients around the nation who have life-threatening aneurysms.
(IMAGE ON THE LEFT) Preoperative 3D reconstruction from a CT scan of the 6.5-cm wide thoracoabdominal aneurysm (see arrow) encroaching upon the renal, bowel, and other arteries leading into the pelvic area. (IMAGE ON THE RIGHT) Postoperative 3D scan of minimally invasive thoracoabdominal stent graft with complete repair of the aneurysm (see arrow), completely isolating the complex thoracoabdominal aneurysm.
Vascular surgeons have had a formidable challenge treating these particular kinds of aneurysms. They typically are large and encroach upon or involve many of the major blood vessels of the abdomen, including those arteries that extend to the liver, spleen, intestines, and both kidneys, as well as those leading into the leg and pelvis. The investigational device, known as a Thoracoabdominal Branch Endoprosthesis, gives surgeons the capacity, for the first time, to repair these aneurysms using minimally invasive techniques.
This first procedure was performed on a 78-year-old male patient on Thursday, March 17, by a team that included Dr. Marin; James F. McKinsey, MD, FACS, Vice Chair of the Department of Surgery at Mount Sinai West and Chief of the Mount Sinai Health System’s Complex Aortic Interventions Program; and Rami O. Tadros, MD, FACS, Associate Program Director, Vascular Surgery Residency, and Associate Professor of Surgery, and Radiology, Icahn School of Medicine at Mount Sinai. Dr. Tadros is the principal investigator of the Phase 1 investigational trial at Mount Sinai.
A TAMBE thoracoabdominal stent graft with side branches for repair of complex aneurysms.
“The patient had severe heart and lung disease caused by atherosclerosis and emphysema from smoking, all risk factors for aortic aneurysms,” says Dr. Tadros. “He had a large, 6.5-cm wide aneurysm that put him at significant risk of rupturing and death. The procedure was complicated and challenging because of the patient’s complex aortic anatomy, but all phases went as planned.” Because of the minimally invasive technique employed by this procedure—small incisions in both groins and the left clavicle without the need for chest or abdominal incisions—the hospital stay was dramatically reduced and his recovery was shortened from many months to two weeks.
“As many as 8,000 to 12,000 patients across the United States may benefit from this procedure if approved for wider use, far more than the 3,000 we are only able to treat now,” says Dr. Marin.
Dr. McKinsey will help lead the team of vascular surgeons who will advance the use of this new generation of stent grafts to repair the most complicated forms of aortic aneurysms. Considered a pioneer in this specialty, Dr. McKinsey has performed more than 200 complex thoracoabdominal aortic procedures using minimally invasive techniques. “Mount Sinai performs more of these types of procedures than any other institution in the region while having some of the best outcomes, measured by long-term survival rates, and fewer procedure-related complications and deaths,” says Dr. McKinsey.