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a Department of Surgery, Duke University Medical Center, Durham, North Carolina
b Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina
c Department of Medicine, Duke University Medical Center, Durham, North Carolina
Accepted for publication July 23, 2008.
* Address correspondence to Dr Hughes, Duke University Medical Center, Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Box 3051, Durham, NC 27710 (Email: gchad.hughes{at}duke.edu).
Presented at the Fifty-fourth Annual Meeting of the Southern Thoracic Surgical Association, Bonita Springs, FL, Nov 7–10, 2007.
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Abstract |
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Methods: Between March 23, 2005, and March 23, 2007, n = 91 thoracic endograft procedures were performed at our institution. Of these, n = 83 (91%) utilized the TAG device and form the basis of this report. Indications for endovascular repair were: fusiform or saccular aneurysm (n = 43; 52%), acute or chronic dissection (n = 30; 36%), acute or chronic traumatic transection (n = 7; 8%), and false aneurysm after prior aortic surgery (n = 3; 4%). A "hybrid" approach involving carotid-carotid bypass (n = 2), stage I elephant trunk procedure (n = 3), aortic arch debranching (n = 7), or complete visceral debranching (n = 5) was required in 20% of patients to create an adequate landing zone.
Results: Primary technical success rate was 98.8% (n = 82/83). Thirty-day rates of mortality and permanent stroke were both 3.6% (n = 3 each). Permanent paraparesis/paraplegia rate was 2.4% (n = 2). The 30-day rate of vascular or device-related complications requiring additional endovascular or open procedures was 7.2% (n = 6). During a mean duration of follow-up of 14 ± 8 months (range 0–28), there was one late death from aneurysm rupture (1.2%) and one late conversion to open repair (1.2%).
Conclusions: "Real world" utilization of the TAG device includes high rates of off-label use (nearly 50%) and "hybrid" techniques (20%) for the treatment of multiple pathologic entities of the thoracic and thoracoabdominal aorta. Regardless, short to mid-term results appear promising. Longer follow-up is needed to determine the durability of this approach.
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Introduction |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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FDA approval was based largely on the results of two large clinical trials of highly selected patients with descending thoracic aneurysms [2, 3]. However, thoracic endografting has other potential off-label applications, including acute and chronic aortic dissection [4] and traumatic aortic transection [5], among others, and little data exist on results with the device as applied to the broad spectrum of aortic pathology encountered in clinical practice. Consequently, the purpose of the present study was to examine our experience with the TAG device for the initial 2 years after FDA approval to better characterize "real world" use (ie, including off-label) and results outside the clinical trial setting.
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Patients and Methods |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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Details regarding the device and technique of delivery and deployment have been previously described [6]. Briefly, the TAG device consists of a self-expanding unibody graft with a nitinol frame and expanded polytetrafluoroethylene fabric. Device fixation is achieved with balloon expansion after endograft deployment. An adequate landing zone was defined as 20 mm or greater length of suitable aorta or a Dacron (DuPont, Wilmington, DE) graft with diameters of 23 to 37 mm, in accordance with device instructions for use.
Preoperative planning of endograft procedures was performed using the TeraRecon system (TeraRecon Inc, San Mateo, CA), which allows highly accurate centerline measurements of flow lumen diameter to assess landing zones as well as iliofemoral access vessels. Intraoperative intravascular ultrasound (IVUS) using the Volcano system (Volcano Corp, San Diego, CA) was used in all aortic dissection cases to completely assess entry and reentry tears and confirm true lumen wire location [7], as well as selectively in other cases as needed. The study was approved by the Duke Institutional Review Board, which waived the need for individual patient consent.
Indications for endovascular repair were fusiform or saccular atherosclerotic aneurysm in 43 (52%), acute (within 2 weeks of symptom onset; n = 14) or chronic dissection (n = 16) in 30 (36%), acute (n = 4) or chronic (n = 3) traumatic transection in 7 (8%), and false aneurysm after a prior aortic procedure in 3 (4%). Criteria for true or false aneurysm repair included symptoms, rapid enlargement (> 5 mm in 12 months), or absolute size. For fusiform aneurysms, this generally included a diameter of 6 cm or greater, whereas for saccular aneurysms, a protrusion of 2 cm or more beyond the aortic wall for the saccular component was considered an indication for treatment in the absence of symptoms [8]. For aortic dissection, indications for repair were complications including secondary aneurysmal degeneration, malperfusion syndromes, or rupture. The presence of traumatic aortic transection, as identified using computed tomography angiography (CTA) or aortography, was considered an indication for repair.
All procedures were performed in the operating room under general anesthesia by a cardiothoracic and vascular surgeon. Adjunctive transesophageal echocardiography (TEE) was used in all cases. Sixteen patients (19%) required an iliac conduit to allow safe introduction of the 20F to 24F introducer sheath necessary for the procedure.
The left subclavian artery was partially or fully covered in 49 patients (59%), of whom 10 (20% of those in whom the left subclavian was covered) underwent adjunctive left carotid–subclavian bypass during the same operation as the endovascular repair. Indications for left carotid–subclavian bypass are outlined in Table 1 [9], and an example of the anatomic anomaly of left vertebral artery arising directly from aortic arch is shown in Fig 1. Temporary adenosine-induced cardiac arrest was used in trauma patients with acute traumatic transection, due to their uniformly hyperdynamic circulation, to minimize device migration during endograft deployment. A hybrid approach involving carotid–carotid bypass (n = 2), stage I elephant trunk procedure (n = 3), aortic arch debranching (n = 7), or complete visceral debranching (n = 5) was required in 20% of patients to create an adequate proximal or distal landing zone. Details of the arch and complete visceral debranching procedures have been previously described [10]. For patients undergoing first-stage total arch replacement (stage I elephant trunk procedure), arch replacement was performed using a modified Mt. Sinai technique [11], with reimplantation of the 3 arch vessels into a trifurcated graft in conjunction with arch replacement using a collared elephant trunk graft with radiographic markers (Vascutek USA, Ann Arbor, MI), which facilitate second-stage endovascular repair. The time interval between stages ranged from 8 days to 7 months.
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All procedural outcomes and complications were prospectively recorded. The patient follow-up protocol was similar to that in prior clinical trials [2, 3] and included a clinical examination, 4-view chest roentgenogram, and CTA at 1, 6, and 12 months postoperatively and annually thereafter. In addition, 3-month follow-up assessment and imaging was obtained in patients with an endoleak identified at 1 month, if the decision for initial endoleak observation was made. Noncontrasted magnetic resonance imaging (MRI), in lieu of contrast-enhanced CTA, was obtained in patients with a serum creatinine level exceeding 2.0 mg/dL. All follow-up assessments were done at the Duke University Center for Aortic Surgery.
This report includes all data collected through the patients' most recent follow-up visits. In addition, the Social Security Death Index was queried to confirm all patient deaths, including patients not returning for follow-up visits. For those patients who died in follow-up, cause of death was confirmed by review of medical records or family interview in all cases. Survival analyses were performed using the Kaplan-Meier method. All data are presented in accordance with the "Reporting Standards for Endovascular Aortic Aneurysm Repair" of the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery [13].
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Results |
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The single case in which primary technical success was not achieved involved an 81-year-old patient with multiple comorbidities who underwent an emergency procedure for a 6-cm distal descending thoracic aneurysm with contained rupture into the left chest. He underwent aortic pavement from the left subclavian artery to the celiac axis using 3 endografts. Despite no endoleak being seen on completion angiography in the operating room, a free aortic rupture into the right chest occurred several hours postoperatively in the intensive care unit, resulting in death. Autopsy demonstrated the distal seal zone of the most distal endograft component to be in an area of thrombus in the aneurysm wall, which subsequently ruptured, rather than in an area of nonaneurysmal aorta (Fig 2).
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Cerebrovascular accident (CVA) was defined as a new neurologic deficit lasting more than 24 hours, determined by clinical examination with or without CT/MRI confirmation, or a finding on CT/MRI of the brain consistent with an acute infarct. CVA occurred in 3 patients (3.6%), all of whom had undergone endovascular repair of distal arch aneurysms and appeared embolic in nature by imaging. None of the strokes occurred in patients undergoing arch debranching procedures. There were no strokes of the posterior circulation or brain stem related to intentional left subclavian artery coverage by the stent grafts.
The rate of new permanent paraparesis or paraplegia was 2.4% (n = 2). The first patient was a 59-year-old woman with end-stage renal disease on hemodialysis who had a history of coronary artery bypass grafting. She underwent urgent repair of an acute type B dissection with associated 6 cm descending thoracic aneurysm and required right carotid–left carotid bypass as well as left carotid–subclavian bypass to create a proximal seal zone. Endovascular aortic coverage extended from the innominate artery to just above the celiac axis. Intraoperative SSEPs and MEPs were normal at the conclusion of the procedure, and she had a documented normal neurologic examination postoperatively. She required evacuation of a left neck hematoma on postoperative day 1 and presented with delayed permanent paraplegia after this latter procedure. Spinal cord function did not recover in follow-up.
The second patient was a 75-year-old woman who had undergone an open distal thoracic aortic aneurysm repair 12 years earlier. She underwent elective endovascular repair of a 9.9-cm descending aneurysm that had developed above the region of the prior open repair. Delayed onset paraparesis developed on postoperative day 1 in the setting of hypotension. Her neurologic deficit improved but did not resolve with CSF drainage and blood pressure augmentation. At the 2-year follow-up, she was ambulatory and had minimal residual lower extremity weakness.
Some degree of delayed onset paraparesis developed in an additional 3 patients during the postoperative period, all of which resolved completely with blood pressure augmentation, with or without CSF drainage, and did not recur.
The rate of vascular or device-related complications requiring additional endovascular or open procedures within 30 days of the original endovascular repair was 7.2% (n = 6). These included:
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Overall, 73 of 83 patients (88%) had at least one follow-up CT scan; of the 10 who did not, 3 died in the perioperative period, 5 did not return for scheduled follow-up, and 2 died of comorbid conditions before return for follow-up imaging. At the latest follow-up, 45 of 73 patients (62%) had decreasing (> 5 mm) aortic dimensions, and aortic dimensions were stable in 27 (37%). Of those patients with follow-up imaging at 6 months or greater, 45 of 51 (88%) had aortic dimensions that decreased by at least 5 mm.
One late conversion to open repair (1.2%) occurred in the midterm follow-up in a 48-year-old man who underwent endovascular repair of an acute type B dissection with contained rupture. The initial endovascular repair was successful in sealing the primary tear, and he initially did well but was noted to have continued retrograde filling of the false lumen of the dissection from a reentry tear in the mesenteric segment. This failed to thrombose in serial follow-up, and his descending thoracic aorta progressively dilated to a diameter of 8.5 cm during a 6-month period. Consequently, he underwent successful open repair of his descending thoracic aneurysm and dissection using cardiopulmonary bypass with deep hypothermic circulatory arrest (Fig 6). He is the only patient in the series to demonstrate expanding aortic dimensions in follow-up.
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In summary, counting those patients undergoing additional late procedures including open conversion (n = 1), treatment of endoleaks (type I/III, n = 4; type II, n=2), carotid–subclavian bypass (n = 2), and bare metal stent treatment of partial TAG graft collapse (n = 1), 10 patients (12%) have required late intervention during midterm follow-up. Nine of these procedures were successful, and the only failure was the patient who died of aortic rupture.
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Comment |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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Because the prior clinical trials have generally included highly selected patients, with strict inclusion and exclusion criteria, we believe the current report better represents results with the TAG graft as applied to the broad spectrum of aortic pathology encountered in clinical practice. The study demonstrates that real world utilization of the TAG device includes high rates of off-label use (nearly 50%) and hybrid techniques (20%) for the treatment of multiple pathologic entities of the thoracic and thoracoabdominal aorta.
Importantly, despite the frequency of hybrid procedures and off-label application, as well as the high percentage (45%) of urgent or emergency cases, the present study demonstrates major morbidity and mortality rates similar to those seen in the clinical trial setting, with perioperative rates of death and CVA of 3.6% (0% mortality rate for elective procedures) and permanent paraplegia/paraparesis of 2.4%. The larger of the two Gore TAG clinical trials [3], which used an open surgical control group, reported 30-day rates of death, stroke, and paraplegia/paraparesis of 2.1%, 3.6%, and 2.9%, respectively.
The rate of vascular access complications in the current series was 1.2% (1 of 83) vs 14% in the TAG trial [3], despite similar need for access conduits (current report 19% vs 15% in the TAG trial). The hospital length of stay was slightly shorter in the present report at 5 vs 7 days. Kaplan-Meier survivals were likewise similar at midterm follow-up, with a 75% overall survival at 28 months in the current report vs 78% at 2 years in the Gore trial [3]. The incidence of overall endoleak (any type) was 11% in both series [3]. Finally, the incidence of decreasing (> 5 mm) aortic dimensions in follow-up was 62% in the present report vs 45% in the TAG trial [3].
Overall, the current series demonstrates that the use of thoracic endografting for the broad spectrum of aortic pathology encountered in clinical practice yields results comparable with those seen in the clinical trial setting and supports the safety and efficacy of thoracic endografting, at least in experienced centers, at midterm follow-up. Similar results have been reported by the Arizona Heart Institute in a single-site investigational device exemption clinical trial that enrolled 158 patients with a broad spectrum of aortic pathology [6]. However, to the best of our knowledge, the present report represents the largest series to date of unselected patients treated outside of the clinical trial setting with the TAG device.
Many questions remain regarding the ideal applications as well as the long-term efficacy of thoracic endografting. As pointed out in a recent editorial [14], thoracic aortic aneurysm is an indolent disease, and midterm follow-up data, as presented in the current report as well as in the previously published clinical trials [2, 3], do not answer the question of procedure durability. However, our finding that aortic dimensions continue to decrease with increasing duration of follow-up is reassuring: in 88% of patients with follow-up imaging at 6 months or longer, aortic dimensions had decreased by at least 5 mm in the current report.
These findings were seen in patients with all types of aortic pathology treated, including aneurysm, dissection, and traumatic transection. In patients with acute traumatic transection, for example, complete aortic remodeling back to normal was uniformly observed on serial follow-up imaging. Likewise, in patients with chronic type B aortic dissection with secondary aneurysmal degeneration—an entity for which significant controversy exists regarding the utility of thoracic endografting, with some investigators even describing the use of endografting for this disease entity as "futile" [8]—decreases in aortic dimensions were typically seen in follow-up. Specifically, in the current report, 13 of 16 patients with chronic aortic dissections treated using endovascular means demonstrated decreasing aortic dimensions in follow-up, including all patients with CT imaging beyond 6 months from the time of stent graft implantation. Regardless, we recognize that long-term follow-up beyond 5 years will be required before endografting can be definitively established as a reliable treatment modality for thoracic aortic disease [14].
Finally, this report, as well as the data reported in prior clinical trials [2, 3, 6], illuminates important economic questions about thoracic endografting. The 2-year follow-up in all of these studies has demonstrated not insignificant rates of non-aortic-related death generally due to the multiple comorbid conditions of patients presenting with these disease states. If 20% to 25% of patients are going to die within 2 years, despite successful treatment of their aortic condition, one must question the long-term cost-benefit of these expensive procedures: A typical device costs of $10,000 to $20,000 per component. In our experience, very few patients are unable to survive to hospital discharge after endovascular repair, and given the aging of the population, serious economic questions regarding the appropriateness of this procedure are likely to arise in this era of increasing health care costs. Consequently, much additional work is needed in this area in the future.
In summary, the present study demonstrates that the application of thoracic endografting to the broad spectrum of aortic pathology encountered in clinical practice yields excellent short-term to midterm results comparable to those seen in highly selected patients in previous clinical trials. Questions remain regarding procedure durability, optimal patient selection, and long-term cost-benefit analysis, which will hopefully be answered in the future with additional studies and longer duration of follow-up.
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Discussion |
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I have a couple of questions. The first one focuses on the treatment of dissections. For those folks who have not gotten into endografting for acute, subacute or chronic dissections, it might be a little counterintuitive to expect such significant remodeling of an aneurysmal dissected aorta once you repave the true lumen, because you think you are going to have continued false lumen flow from below through the distal fenestrations. We have been very surprised to see complete healing and remodeling of that usually aneurysmal proximal descending aorta once you cover the primary proximal tear. Since the dissected aorta tends to heal and remodel all the way down to the level of the end of the stent graft, have you changed your approach in terms of how much dissected aorta you treat? Do you just cover the proximal tear or have you started repaving most of or all of the descending thoracic aorta in hopes that the entire area of the aorta that has the graft within it is going to remodel?
DR HUGHES: Thanks, and I also would like to thank Dr Kern for not mentioning how late I got the manuscript to him.
I agree about the real world. I guess it is not necessarily real world, and there is definitely a significant learning curve to these procedures, especially with dissections and transections, the latter of which you might think would be a very easy thing to treat but actually can be among the most challenging of cases, especially with a highly angulated, small aortic arch.
But with regards to the dissection question, as Dr Kern is well aware, that is a highly controversial area, and even the recently published STS [Society of Thoracic Surgeons] expert guidelines, which I see Dr Kouchoukos sitting here, questioned the utility of thoracic endografting for the treatment of chronic dissection with associated aneurysm. But our experience does mirror what Dr Kern is describing, in that the most common area to dilate with chronic type B dissections is the proximal descending thoracic aorta just opposite the primary tear. This is usually where patients develop an aneurysm, and even though they have a double-barrel aorta going down even through the aortic bifurcation, it is much less common to get aneurysms more distally. So we typically have just covered the primary tear and usually extend it at least 10 cm beyond the primary tear; usually you are looking at a 15-cm-length endograft.
That being said, we look very carefully at the preoperative CT [computed tomography] scans, which with 1-mm cut reconstructions are very good at looking for distal fenestrations, and also we use intraoperative IVUS [intravascular ultrasound] on all these cases, which I think is mandatory. And if we see additional distal fenestrations in an area that would be amenable to covered stent placement, for instance, more distally within the descending thoracic aorta, we will cover that because we think that will promote more distal thrombosis of the false lumen. Our experience has mirrored what Dr Kern has described. These aortas do shrink down in size even if they are chronic dissections, and if they are subacute or acute dissections, the aorta frequently remodels completely back to normal, at least in the area of the stent graft.
However, we have not gone after every single fenestration at least at this point in our experience. Obviously, the more aorta you cover, the higher the risk of paraplegia. So there is a tradeoff there. And if they don't have aneurysm distally, it is unclear to me whether you need to go after those distal tears, but certainly if they had aneurysm distally, I would be very aggressive with even covered stents into branch vessels and things of that nature. So I think you have to individualize it.
I would mention one thing about the chronic dissection question is that we have actually put CardioMEMS aneurysm sac pressure monitors (CardioMEMS, Inc, Atlanta, GA) into the false lumens of these dissections with aneurysm. For those of you not familiar with these monitors, they are noninvasive pressure sensors. They are designed for abdominal aneurysms and are deployed into the aneurysm sac endovascularly at the time of the procedure. The sensor then sits outside the stent graft. And when the patient comes back to the clinic, you can measure the pressure in the aneurysm sac and compare it to the systemic pressure, and generally if it is less than 50%—some people say less than 70%—of the systemic blood pressure, the aneurysm is considered excluded. And when we put these into the false lumen of chronic dissections, when you cover the primary tear and the aneurysm is thrombosed, those pressures are very low, suggesting that there is not retrograde pressure transmission from these distal fenestrations, at least in the cases where we have put the CardioMEMS in.
DR KERN: I have one more quick question. You have had no aneurysm expansion from type II leaks through intercostals, but you will at some point. What is going to be your plan?
DR HUGHES: The subclavians we have all embolized.
DR KERN: Yes. What about the intercostals, though?
DR HUGHES: People have described CT-guided transthoracic glue or coil embolization. I have discussed this with our vascular radiologists. I think it would depend on the situation and if the patient was a candidate for an open conversion or not.
DR MARC MOON (St. Louis, MO): That is what I was just going to suggest. We can always do standard surgery.
DR JOHN S. IKONOMIDIS (Charleston, SC): Chad, I enjoyed your presentation very much. I would like to ask a question about your indications for transections. First of all, what was the denominator over the 2-year time period? In other words, how many aortic transections did you see in total and how many of them did you end up stent grafting? The concern I have with the transections is that these often happen in young people, and they have small descending thoracic aortas. The Gore device goes as low as a 26 and it only tolerates about a 20% downsizing. Have you encountered problems with that? Specifically, I noticed you had a couple of stent involutions. Were those related to transections? What is your lower limit for the size of the aorta in deploying the smaller Gore device?
DR HUGHES: Those are all excellent questions, and, as I mentioned, a transection you would think would be easy to treat but it is actually very challenging. The denominator is, I think in this series it was three or four acute transections, and I would say over that time period I only remember one patient we didn't stent, and it wasn't that the aorta wasn't favorable, but the patient had such a severe head injury they weren't going to survive, and so it was clear that there was no point to treat their aorta. But we generally treat every transection. That being said, they are generally young patients. Their aortic diameters are almost uniformly less than 23 mm and their arches are very angulated, which, as you know, is the other compounding problem.
There were two TAG [W. L. Gore and Associates, Flagstaff, AZ] collapses in this series, and we have had one after 3-27-07. Two of the three were in trauma patients, all were in arch cases, and all were successfully treated with bare metal stents. But what we have done now, and actually these past 2 weeks we did three of them, we now routinely reinforce the proximal end of the TAG graft with a bare metal stent 100% of the time and that way we don't have to worry about late collapse. If the aorta is 20 mm in diameter or larger, I feel comfortable with this approach; if it is 18 mm, I probably wouldn't do that. In that situation, Zenith makes iliac cuffs for AAA that you can use. The problem is that the shaft length is not long enough to reach up to the proximal descending thoracic aorta in a tall person. Fortunately, the times we have used iliac cuffs they have been in small people where we can get them to reach. But smaller sizes are going to be coming, hopefully, in the near future that will help address this, as well as the conformable stent graft, which I know you are also aware of, which will help with this.
I think the other question is what is going to happen with these stent grafts when these people get old and the aorta gets bigger? My guess is that there will probably be some migration. As I am sure you have seen in your transection patients, that aorta remodels back to normal; it is healed. If you see somebody a year after a stent graft for transection, you can't tell they had a transection. I suppose we may see some migrations in the future. Whether that is going to be clinically significant, I think we will have to wait and see.
DR MOON: Again, let's not forget you can do open surgery to repair a transection.
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