Study Reveals that Thoracic Endoluminal Grafting is a Feasible Alternative
TO Open Surgical Repair J Vasc Surg. 2007 Sep; 46(3):413-20. Application of Endograft to Treat Thoracic Aortic Pathologies: A Single Center Experience. Rodriguez JA, Olsen DM, Shtutman A, Lucas LA, Wheatley G, Alpern J, Ramaiah V, Diethrich
PHOENIX, Sept. 28 /PRNewswire/ -- The Arizona Heart Institute announced today that results from its single-center study of the effectiveness of endoluminal grafting for thoracic aortic pathologies were published in the September 2007 issue of the Journal of Vascular Surgery. Presented in the leading subspecialty, peer-reviewed journal in the field of vascular surgery, the study showed that patients with potentially life-threatening conditions of the thoracic aorta, including thoracic aortic aneurysms, can be treated effectively using a less invasive method associated with minimal blood loss, faster recovery, shorter hospital stays and decreased risk of death.
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"This study represents a significant milestone in managing complex conditions of the thoracic aorta," reported Julio A. Rodriquez-Lopez, M.D., lead author and medical director of Peripheral Vascular Services at the Arizona Heart Institute. "In our research findings and overall experience with thoracic endoluminal graft (ELG) repair, we see a significantly less overall complication rate, including death, compared to published adverse events associated with open surgical repair," continued Rodriguez. "This is greatly due to the minimally invasive nature of the technique as well as our ability to proactively treat patients with elective, non-emergent procedures earlier in the disease process."
Thoracic aortic aneurysm, or "bulging" of the major artery which arises from the heart, is a serious condition prone to rupture and sudden death. According to the Society for Vascular Surgery, less than half of all patients who experience a rupture of a thoracic aortic die before reaching the hospital, making it the 13th leading cause of death in the U.S. Furthermore, studies report that emergent, open surgical repair of a ruptured thoracic aneurysm carries a 25 to 50 percent risk of death. ELGs, which are metal stents covered by a fabric graft material, offer a lower-risk alternative to open surgical repair. The device is delivered under X-ray guidance via a catheter passed through an artery near the groin. The ELG is then positioned and expanded within the aorta at the site of the problem, restoring blood flow, providing significant pain relief and reducing the risk of rupture. Depending on their general condition, patients typically return home within a few days.
"It is evident that ELGs represent an important means of treating thoracic aortic pathologies," said Venkatesh G. Ramaiah, M.D., study co-author and director of Peripheral Vascular and Endovascular Research at the Arizona Heart Institute. "To date, this is the largest published series of patients treated with thoracic ELGs for a variety of thoracic aortic pathologies. After more than 500 cases performed at the Arizona Heart Institute, complication rates, including death, compare favorably with open surgical repair, suggesting that endoluminal grafting is a favorable alternative in the treatment of thoracic aortic pathologies," said Ramaiah.
"We are very pleased with the results from this important study which further supports the movement toward minimally invasive management of aortic disease," said Edward B. Diethrich, M.D., medical director, founder of the Arizona Heart Institute and study author. "Since the early 1990s, we have pioneered a multitude of new technologies, treatments and therapies for cardiovascular disease. Clearly, the institution of endoluminal grafting represents a hallmark in the changing treatment paradigm for patients with potentially lethal and debilitating diseases of the thoracic aorta. Our team looks forward to continued research and scientific endeavors to hopefully, in the future, make inroads in the prevention of all cardiovascular diseases," continued Diethrich.
From March 1998 to March 2006, repair of the thoracic aorta using an ELG was performed on 406 patients at the Arizona Heart Institute, including 324 patients receiving a commercially available FDA-approved implant with the remaining patients receiving investigational devices. Patient population included those eligible for open surgical repair and those with prohibitive surgical risk. The majority of treated patients had atherosclerotic aneurysms (157; 48.5%) and one quarter (82; 25.3%) had type B dissections. The remaining patients were treated for thoracic aortic pathologies including penetrating ulcers (34; 10.5%), pseudoaneurysms (26; 8%), transections (11; 3.4%), aorto- bronchial fistulas (9; 2.8%), aorto-esophageal fistulas (1; 0.3%) and embolization (4; 1.2%). One hundred cases (31.5%) were non-elective and 49 (15.1%) were ruptures. All patients received a follow-up evaluation at six months and yearly, with a follow-up range between one and 70 months (average 17 months).
The study results revealed the following:
-- Sac Size (only among aneurysm component): Preoperative aneurysm sac
size ranged from 5 to 12 centimeters, with an average size of 6.3 cm.
Sac shrinkage occurred in 65% (102 of 157) of patients. Average
postoperative sac size of 5.4 cm was noted in a mean follow-up of 20.4
-- Endoleaks: Endoleak, or blood leakage around the ELG, creates
insufficient seal to the aorta wall. Four types of leaks have been
defined and range from type I (the most serious and requiring
correction) to type IV (graft porosity, rarely seen with current
devices). In the study, the occurrence of early endoleaks was low and
included 18 (5.5%) type I, four (1.2%) type II, and two (0.6%) type III
-- Paraplegia: Thoracic ELG repair can cause decreased blood supply to the
spinal cord, leading to paraplegia. In this study, paraplegia occurred
in five (1.5%) patients and paresis (slight or partial paralysis) in
three (0.9%); two of the latter improved and one resolved completely
prior to discharge. Paraplegia remains low as a complication and
expectedly increases with difficult anatomy, specific conditions or
open surgical approach. Associated paraplegia with open repair is
estimated at 4%.
-- Mortality: At short-term follow-up, 18 (5.5%) deaths related to the
underlying thoracic aortic pathology occurred within the first thirty
days of the procedure, including three intraoperative deaths. Late
mortality was 9.6% with 31 deaths unrelated to the procedure or
-- Complications: The overall complication rate was 22.7%, 14.2% (46) in
elective cases and 8.5% (28) in non-elective cases. The vast majority
of these were minor and easily managed with satisfactory outcomes.
Thoracic Aortic Aneurysms and Related Conditions
The aorta is the largest artery in the human body which carries blood away from the heart, with the thoracic aorta being the portion of the aorta coursing through the chest. When a weak area of the thoracic aorta expands or bulges like a balloon, it is called a thoracic aortic aneurysm (TAA). TAAs are often caused by atherosclerosis, or hardening and weakening of the arteries. An aortic dissection, which is often associated with high blood pressure, occurs when blood flow forces apart and weakens the aortic wall layers, often leading to aneurysmal dilatation. A pseudoaneurysm, also known as a false aneurysm, is an "out pouching" of the aorta involving a defect in the two innermost tissue layers or the aorta. True aneurysms, in contrast, are vascular out pouchings involving all three tissue layers of the aorta. Less common yet serious conditions such as a penetrating ulcer of the aorta or a fistula, which is an abnormal connection or passageway between the aorta and other organs, can cause fatal hemorrhage. Trauma from a fall or motor vehicle accident may cause the thoracic aorta to transect and rupture.
Left untreated, TAAs can burst or rupture, leading to severe internal bleeding, shock and death. Approximately half of all TAAs go undetected because patients do not experience symptoms. Presence of symptoms may depend on the location and size of the aneurysm and whether a dissection is present. Symptoms of aortic rupture or dissection can occur suddenly with severe, sharp pain in the chest or upper back. Patients who experience these symptoms should seek immediate medical attention.
Early detection of aortic aneurysms can prevent sudden death, therefore patients with a family history of aortic aneurysm or other connective tissue disorders should notify their physician about their risk of thoracic aortic aneurysm. Thoracic aneurysms can be easily diagnosed using simple imaging tests including MRI and CT scan. If the TAA is small (around four or less centimeters in diameter), the physician may simply recommend monitoring the size and shape of the aneurysm every six months while also addressing other risk factors such as high blood pressure to reduce the degree of pressure on the weakened area of the aneurysm. Large, symptomatic TAAs require prompt attention to prevent rupture and are typically treated by a vascular surgeon with either open surgical repair or less invasive, endoluminal graft repair as described in this respect.
About the Arizona Heart Institute
Since 1971, the Arizona Heart Institute has been dedicated to the prevention, detection and treatment of cardiac and cardiovascular disorders. Its team of board-certified specialists uses the latest means to diagnose the threat of heart and vascular disease before it strikes. The Arizona Heart Institute performs nearly all diagnostic tests on site, providing patients with the convenience of a complete, same-day analysis on an outpatient basis. Patients requiring interventional procedures such as endoluminal grafting are treated and cared for by our same team of specialists at the Arizona Heart Hospital. For more information, visit the Arizona Heart Institute Website at http://www.azheart.com.
Learn More about Thoracic Aortic Aneurysms
Endovascular Treatment of a Descending Thoracic Aortic Aneurysm Dr. Edward B. Diethrich and Dr. Grayson Wheatley Apply New Technology to a Thoracic Aneurysm
Related Links and References
Abstract - Application of endograft to treat thoracic aortic pathologies:
A single center experience
International Society of Endovascular Specialists
International Congress XXI Endovascular Interventions
|SOURCE The Arizona Heart Institute|
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