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Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
Accepted for publication April 14, 2009.
* Address correspondence to Dr Pochettino, Division of Cardiovascular Surgery, University of Pennsylvania Health System, 6 Silverstein Pavilion, 3400 Spruce Street, Philadelphia, PA 19104-4283 (Email: alberto.pochettino{at}uphs.upenn.edu).
Presented at the Fifty-fifth Annual Meeting of the Southern Thoracic Surgical Association, Austin, TX, Nov 5–8, 2008.
| Abstract |
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Methods: Between June 2005 and June 2008, 150 patients were treated surgically for acute type A aortic dissection at the Hospital of the University of Pennsylvania. Of these, 78 were DeBakey I dissections: 42 patients underwent standard open repair, while 36 underwent additional thoracic stent-grafting by the open arch. Arch repairs were performed with a combination of retrograde cerebral and selective antegrade perfusion.
Results: Mean follow-up was 15.9 months. Hospital mortality was 5 of 36 (14%) for stented and 6 of 42 (14%) for nonstented repairs. Postoperative strokes were 1 of 36 (3%) in stented versus 4 of 42 (10%) in nonstented repairs (p = not significant [NS]) despite longer circulatory arrest times in the stented group; 60 ± 13 minutes versus 41 ± 18 minutes (p < 0.0001). Transient paraparesis was 3 of 36 (9%) in the stented versus 1 of 42 (2%) in the nonstented group (p = NS) with no permanent deficits. Stented thoracic false lumen obliteration was achieved in 24 of 30 (80%) with 5 of these (17%) achieving complete thoracoabdominal false lumen thrombosis. Eight of 31 (26%) stented patients underwent endovascular reintervention to achieve the desired false lumen obliteration. Open thoracoabdominal aortic aneurysm repairs were performed in 0 of 31 in the stented group and 4 of 36 (11%) in the standard group (p = 0.083).
Conclusions: Antegrade stent graft deployment during acute DeBakey I dissection repair is a safe method to obliterate the thoracic false lumen. Endovascular reinterventions were well-tolerated. "Elephant trunk" thoracic stent-grafting as part of the repair for acute DeBakey I dissection gives equal short-term results compared with standard repair, and lowers morbidity and mortality during follow-up.
| Introduction |
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| Patients and Methods |
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Statistical analysis was conducted to compare preoperative characteristics and postoperative outcomes in the stent and control groups using SPSS version 15.0 (SPSS Inc, Chicago, IL). The Student t test was used to assess differences between groups for numerical variables. The Fisher exact test was used to assess differences between groups for categoric values (Pearson
2 was used for categoric variables with more than two categories).
Surgical Technique
As soon as the diagnosis of acute type A dissection was confirmed or highly suspected the patient was taken directly to the operating room. Computed tomographic angiography and echocardiography were the primary diagnostic imaging techniques. All patients had invasive monitoring consisting of arterial line and pulmonary artery catheter. In unstable patients central venous access was obtained up front, with a Swan-Ganz catheter advanced at the conclusion of the procedure. After endotracheal general anesthesia, TEE was performed to confirm the diagnosis and assess proximal valve-root reparability. When CTA was not available for measurement of the dissected descending thoracic aorta, TEE was utilized to size the diameter of the distal arch and the mid-descending thoracic aorta.
Arterial cannulation for the stented versus nonstented repair was as follows: femoral in 19 of 36 versus 22 of 42, axillary in 10 of 36 versus 6 of 42, and central (dissected ascending aorta or arch) in 7 of 36 versus 14 of 42.
After median sternotomy, right atrial cannulation with a two-stage cannula was used. An additional superior vena cava cannula was placed, to be converted into the inflow cannula for retrograde cerebral perfusion during part of the hypothermic circulatory arrest. After initiation of cardiopulmonary bypass, flow was ascertained in both carotid arteries with two-dimensional Doppler evaluation. A left ventricular vent was placed to ensure myocardial decompression. Core cooling was carried out to flat line electroencephalogram when available or to 50 minutes total cooling [13, 14]. The aorta was cross-clamped as soon as ventricular fibrillation ensued. Direct coronary ostial antegrade hyperkalemic cold blood cardioplegia, as well as retrograde cold blood cardioplegia, were used intermittently for myocardial protection. During systemic cooling the proximal ascending aorta was debrided to the sinotubular junction. Repairs were performed whenever feasible and consisted of commissural resuspension with 4-0 pledgeted sutures and Teflon neomedia (DuPont, Wilmington, DE) reinforcement of the dissected sinuses [10]. Use of Cryolife Bioglue (CryoLife Inc, Kennesaw, GA) was minimal in nonstented patients and none in stented patients, reflecting surgeons' preference. Root replacement was performed if repair was not possible.
Once adequate core hypothermia was reached, circulatory arrest was initiated, with retrograde cerebral perfusion administered through the snared superior vena cava cannula, at flows of 150 to 300 cc/minute of blood at 12°C to maintain a jugular venous pressure between 25 and 30 mm Hg. The entire residual ascending aorta and the majority of the lesser curvature of the arch were debrided. The lip of aorta containing the arch vessels was repaired with Teflon felt neomedia. Such repair was extended onto the proximal descending thoracic aorta to achieve proximal obliteration of the false lumen. In the nonstented patients arch repair was now complete, and an appropriately beveled Dacron graft (Vascutec Ltd, Renfrewshire, Scotland) was sewn to the repaired arch with 4-0 Prolene (Ethicon, Somerville, NJ).
In the stented cohort, after the first 6 patients we added selective antegrade cerebral perfusion by either the axillary cannulation or by manually inflated balloon-tipped cannulae placed in the innominate and the left common carotid arteries [15]. Selective antegrade cerebral perfusion was used only in the stented patients.
The diameter of the proximal descending thoracic aorta had been measured from the preoperative CT scan and (or) the intraoperative TEE. A GoreTAG (W. L. Gore & Associates, Flagstaff, AZ) thoracic aortic stent graft was chosen to be 10% to 15% larger than the measured proximal aortic diameter. Early in the study 10 cm length grafts were chosen for fear of paraplegia which was changed to 15 cm as the paraplegia risk did not materialize. The stent graft was deployed into the true lumen of the descending thoracic aorta under direct vision without the use of a guidewire. The proximal scallops of the GoreTAG stent graft were deployed to abut the origin of the left subclavian on the greater curve, and the edge of the repaired aorta on the lesser curvature (Fig 1). The stent graft was gently balloon dilated along its entire length to achieve aortic apposition using a soft Foley catheter with a 30 mL balloon. The stent graft was further fixed proximally by placing multiple 4-0 pledgeted sutures along the repaired distal arch-proximal descending thoracic aorta. An appropriately beveled Dacron graft was then sewn to the repaired and stented distal arch using a running 4-0 Prolene suture. The TAG stent graft was incorporated into the arch suture line along the lesser curvature.
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| Results |
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Despite the higher circulatory arrest time, the postrepair strokes were 1 of 36 (3%) in stented patients and 4 of 42 (10%) in nonstented patients (p = NS). Transient paraparesis occurred in 3 of 36 (9%) stented patients and 1 of 42 (2%) nonstented patients (p = NS) and resolved in all patients. Postoperative renal failure was seen in 6 of 36 (17%) stented patients, with 3 requiring hemodialysis, versus 7 of 42 (17%) in nonstented patients, with 4 requiring hemodialysis.
Among the surviving 31 stented patients, follow-up CTAs are available in 30 (1 patient has refused follow-up CTA). In 5 of 30 (17%) obliteration of all residual thoracoabdominal false lumen is documented (Table 3). An additional 19 of 30 (63%) achieved false lumen obliteration within the thoracic aorta, for a thoracic false lumen obliteration of 24 of 30 (80%). In these 24 patients the maximal descending thoracic aortic diameter was 29.1 ± 4.3 mm. The remaining 6 of 30 (20%) did not achieve false lumen obliteration at any level. In these 6 patients the maximal descending thoracic aortic diameter was 38.1 ± 5.3 mm. Figures 3 to 5
show M2S three-dimensional rendering of the three different anatomic outcomes. Early in our experience we accepted the occasional failure to achieve at least stented thoracic aortic false lumen obliteration. As we became more experienced in endovascular treatment of complicated acute type B dissection, we decided to consider endovascular reintervention to treat this group. Eight of 31 stent patients underwent endovascular reintervention to achieve thoracic false lumen obliteration. No morbidity or mortality was encountered in these 8 patients.
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In the nonstented group, one patient required a proximal reoperation and 4 of 36 (11%) required open thoracoabdominal aortic aneurysm repair. In the stented group one patient has required proximal reoperation and none has required open distal reoperation.
| Comment |
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Parallel to the progress in surgical management of acute type A dissection, improvement in our understanding and management of acute type B dissection has also occurred. It has become clear that while the short-term morbidity from uncomplicated type B aortic dissection is minimal, over a five-year period upward of 80% of these patients experience aneurismal degeneration of their descending aorta [19, 20]. The reported rate of aneurismal degeneration of the residual descending thoracic dissections averages 4.1 mm per year [21], and the risk of rupture becomes significant at 6 cm maximal diameter [6]. The morbidity and mortality associated with a standard open repair of these thoracoabdominal dissecting aneurysms is significant and approaches from 8% to 15% in an age-dependent manner [1–9]. In addition, open repair frequently exposes these patients to significant perioperative cardiopulmonary or renal failure and concomitant spinal cord ischemia or cerebral vascular accident irrespective of the operative technique employed.
Given the high operative mortality for open repair of complicated acute type B dissection, the use of stent grafting in their management has grown [22]. At present we and other groups feel endoluminal stent grafting is the treatment of choice of complicated type B dissections [23]. While use of stent-grafting in uncomplicated type B dissection is still a subject of investigation, some reports have suggested favorable short-term results when endovascular techniques achieve complete or partial obliteration of the false lumen and stabilize the descending thoracic aorta [24–27]. Long-term follow-up on these patients is unavailable. However, data are available that link the size of residual false lumen in the descending thoracic aorta to the risk of aneurismal degeneration of such aorta [28]. It is therefore theorized that stabilization of the thoracic aorta with appropriate stent-grafting might decrease or eliminate the risk of future vascular rupture.
As we became proficient with stenting of acute type B dissections with favorable outcomes, we felt we could extend their application to improve our acute DeBakey I surgical repairs. We first applied this hybrid approach in the setting of arch tears, where we would have been forced to perform a total arch replacement or a complex arch repair. Neomedia repair of the arch remnant with added descending "elephant-trunk" stent-grafting was faster to perform than a total arch replacement and gave good results in the first 6 patients. Extension to patients without arch tears would prevent aneurismal degeneration in the distal arch-proximal descending thoracic aorta. Divergence of opinions among our aortic group provided the opportunity to compare, in a contemporary fashion, our standardized approach to the addition of stent grafting via the open arch.
One of the limitations of the technique is the use of a single US Federal Drug Administration (FDA)-approved device not designed for this antegrade deployment. The flexibility of the device and its speed of deployment were advantageous. The temperature-dependent flexibility of the algiloy metal required the securing proximal sutures during the hypothermic period and may have contributed to some of the failed false lumen obliteration of the stented thoracic aorta. Placement of the TAG graft in a warm bath prior to deployment has been suggested [29], but we did not find a significant difference. Other groups, in environments with lesser regulatory constraints, have utilized stent-grafts customized for this application with favorable results [30, 31]. On the other hand we felt it was important to demonstrate that even a FDA-approved device could be utilized effectively in the US to achieve the stated goal of obliterating the thoracic aortic false lumen without any increase in risk to the patient and with demonstrable benefits over the short-and midrange follow-up.
Early in our experience, reintervention in cases of persistent patent thoracic false lumen was not utilized. We were somewhat "forced" to intervene about one year into the study in a patient who developed acute mesenteric ischemia. The malperfusion was readily treated with a distal stent graft extension. From that point forward all patients with persistent patent thoracic false lumen were offered the option of reintervention. All patients who underwent endovascular reintervention achieved obliteration of thoracic false lumen without morbidity or mortality. Five of the 6 patients with persistent thoracic false lumen were treated early in our study when we did not offer reintervention and one patient declined it. The use of a hybrid operating room to perform DeBakey I repairs would allow immediate evaluation of acute thoracic false lumen obliteration. We did not have it available in this study, and anatomic evaluation was performed once the patient had fully recovered and was typically ready for discharge. Just as TEE has become the standard to evaluate the immediate result of our cardiac reparative technique, we can envision a real-time evaluation of our aortic intervention to ensure we leave the operating room with the desired outcome.
The incomplete CTA follow-up among nonstented patients (66%) remains a weakness of this study, yet we are unaware of other contemporary comparisons of DeBakey I dissection repair techniques of stenting versus nonstenting.
This study clearly represents a work in progress. Improved short-term and midterm results were achieved without increase in acute morbidity and mortality. With further refinement of the technique and possibly improved custom made stent grafts the results are likely to improve further and become more universally applicable to the benefit of patients affected by acute DeBakey I dissections.
| Discussion |
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We know that obliteration of the false lumen has been important in limiting the subsequent growth of the dissected aorta and therefore the risk of reoperation. And I was happy that you pointed out in your presentation that actually complete obliteration was equal between the two groups at follow-up, 17%.
I appreciated your video also as I was going to ask you some of the technical aspects of how you do this. I am interested in what the indications were for the reintervention in both groups. In the stented group you had one endovascular reintervention for mesenteric ischemia, but I was curious what the other ones were and why did the other group require an open procedure in four patients? You have demonstrated that this is feasible to add this stent to this repair without increasing operative morbidity and mortality, but your abstract and the paper concluded that your stent addition lowers mortality and morbidity during follow-up. I think that may be incorrect, because perhaps what you have just demonstrated is that the addition of the stent to the proximal descending aorta just allows you to go back again and add another stent as opposed to doing an open procedure. I believe that your work should stimulate a larger patient comparison to see if the additional operative time and cost are really worthwhile, as a lot of people would argue that you are treating an asymptomatic type B dissection with the addition of the stent. Thank you very much.
DR POCHETTINO: Thank you for the comments. We added selective antegrade cerebral perfusion in the stented group because the operation was taking too long to safely perform it with only the standard retrograde cerebral perfusion. The first six patients did not have selective antegrade, but after that I just felt it was not appropriate to be on circulatory arrest for 55 to 60 minutes without selective antegrade cerebral perfusion. Because of the differing techniques, the comparison of neurologic outcome is not fair. Performance of the procedure as described, however, did not cause worse outcome compared to the standard repair. I wanted above all to make sure this new method was not worse than the standard procedure, and I think I have demonstrated that.
On your second question, you are right to point out that the added stent is primarily designed to address future problems. As part of my practice I do a lot of thoracoabdominal repairs, and I feel that preventing the need for such morbid procedure is highly desirable. Dissecting thoracoabdominal aneurysm repairs have not been required among patients stented at the time of their DeBakey I repair. I think this will lower long-term mortality among stented patients. Clearly, it is imperative to avoid a higher mortality up front to justify the change in surgical management. I think I have demonstrated no increase in short-term morbidity and mortality. Furthermore, I have demonstrated that to date, three years from the beginning of this study, the thoracic aorta in 80% of these patients remains nondissected.
Next I want to address the indications for endovascular intervention. Of the seven patients with persistent dissected thoracic aorta, three were among the first six patients. As we were developing the technique, we had to develop algorithm for sizing, deployment, and securing of the stent. Some of the early "failures" reflected this learning curve. In later patients I was not "forced" to intervene until a patient who developed recurrent mesenteric malperfusion a week postrepair. I addressed the malperfusion with an additional thoracic stent graft. I was very pleased by the outcome. Thereafter, I saw a residual thoracic dissection in seven more patients. I decided to approach these patients and explain to them that we had not achieved obliteration of the thoracic false at the original surgery. I explained to those patients the potential benefit of completely obliterating the thoracic dissection to avoid aneurismal degeneration. All but one patient agreed to proceed to reintervention to achieve thoracic obliteration of the false lumen.
DR R. MORTON BOLMAN III (Boston, MA): Alberto, I really appreciated your presentation and it is very intriguing. Just a quick technical question. Do you balloon dilate the proximal and distal end of these stents in these very friable aortas to try and fix them, and secondly, do you use a uniform length graft in this setting?
DR POCHETTINO: I do balloon them. I have mostly used a Foley balloon. The Tri-Lobe Gore balloon is too stiff and it just doesn't work in this setting. I have used a Coda balloon a couple of times. I am a little afraid of using the Coda balloon because it could put excess stress on the aorta and potentially rupture a freshly dissected aorta. The Foley balloon is a lot softer and does not develop much pressure. The downside of low-pressure ballooning is that some of the distal landing zones were not completely expanded, requiring on occasion to go back and place a distal stent to fully expand the distal landing zone.
We started with 10 cm stent grafts because we were afraid of causing paraplegia. We saw none except one minor, temporary paraparesis, and then moved to 15 cm length, which is I what I use at this point.
DR JOSEPH S. COSELLI (Houston, TX): Very nice presentation. I am sure this technique will be used more often. I have two comments and a question. First, we have to be careful when choosing an endpoint. We noticed in following patients with dissections beyond the left subclavian artery, that the thrombosis of the false lumen is not always the end of the story. In many of these patients, even with the thrombosed false lumens, they are still pressurized and continue to expand. So I think we have to be careful of our endpoint.
Secondly, if I heard your presentation right, in evaluating your data, and I will be looking forward to the manuscript at some point, I was very concerned about the number of patients lost to follow-up in your nonstented group. It seemed like a very, very substantial number were lost; this I think would need some explanation because it may actually skew your results if you had more information there.
And then my final question is related to the dilatation issues: nitinol really is designed to dilate up at normothermic temperatures. Now, at these low temperatures at which you are applying it, the nitinol may not necessarily expand properly; therefore, some ballooning of some fashion is almost certainly going to be necessary, placing the friable wall between the true and the false lumen at some risk. You can actually push the distal end of that graft through the septum between the true and the false lumen and create an additional fenestration. Thank you.
DR POCHETTINO: Those are all very good points. We do need to balloon the stent graft. Your group reported on the option of warming the graft before deploying in a circulatory arrest situation, which I have tried. It hasn't been quite as practical. Clearly, we need to be careful in ballooning these friable aortas.
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