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Ann Thorac Surg 2004;78:109-116
© 2004 The Society of Thoracic Surgeons
a Center for Aortic Surgery, Marfan Syndrome and Connective Tissue Disorders Clinic and Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
b Department of Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
c Department of Cardiothoracic Surgery, Lahey Clinic, Burlington, Massachusetts, USA
Accepted for publication February 18, 2004.
* Address reprint requests to Dr Svensson, The Cleveland Clinic Foundation, 9500 Euclid Ave/Desk F 25, Cleveland, OH 44195, USA
e-mail: svenssl{at}ccf.org
Presented at the Fiftieth Annual Meeting of the Southern Thoracic Surgical Association, Bonita Springs, FL, Nov 13–15, 2003.
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Abstract |
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METHODS: Records were reviewed for 94 consecutive patients (age 67 ± 11 years, 47% men) who underwent the procedure between November 1990 and February 2003. The trunk was implanted as an extension of the ascending aorta and arch graft in 83 of 94 (88.3%) patients, distal arch graft in 8 of 94 (8.5%) patients, and in 3 distal to the left subclavian artery (3 of 94 patients [3.2%]). Aortic dissection was present in 37 (39.4%) patients and Marfan syndrome was present in 7 (7.4%). Twenty-three were reoperations (24.5%). In 9 patients, the trunk procedure was adjunctive in preparation for the second operation. In 15 patients, the anastomosis was completed between the left subclavian and common carotid arteries. Coronary artery bypass was performed in 36 (38.4%) and aortic valve operation in 55 (58.5%; 20 root sparing repairs, 16 composite grafts and 19 replacements) patients.
RESULTS: There were two early 30-day in-hospital deaths (2.1%) and 5 permanent strokes (5.3%). Eleven died before the second-stage procedure. Forty-seven (57%) underwent second-stage procedures; 40 by thoracotomy and 7 by stent graft insertion, including 2 thoracoabdominal aneurysm repairs with visceral bypasses before stent grafting with 4 early deaths (8.5%). Five-year survival was 34% without a second-stage procedure versus 75% 3-year survival with it.
CONCLUSIONS: With a current total of 142 elephant trunk procedures, we found it is safe and should be used more with initial cardiac surgery before descending or thoracoabdominal aorta repair.
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Introduction |
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| Dr Greenberg discloses that he has a financial relationship with Cook, Inc.
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In 1983 Borst and colleagues [1, 2] introduced the elephant trunk procedure (ETP) to facilitate planned staged procedures. The initial problems with this operation included a high risk of early rupture at the distal anastomosis and air embolism into the distal aorta with visceral ischemia [3]. Therefore, in the early 1990s, the technique was modified by inverting the graft within itself and then sewing the doubled-over edge into position beyond the left subclavian artery, and then withdrawing the inner inverted tube for the arch repair [3]. Subsequently, a technique was described for constructing the anastomosis between the left common carotid artery and the left subclavian artery for those patients with a dilated distal arch, complex arch pathology, or an aberrant right subclavian artery [4]. Indeed, with increasing experience and improved results, we now perform adjunctive elephant trunk procedures in patients undergoing preparatory cardiac surgery before descending or thoracoabdominal aneurysm repairs who, in the past, would not have had an adjunctive ETP. Therefore, with the introduction of these newer modifications, we wished to evaluate our results. We also included the influence of timing of the second-stage procedure on survival as opposed to performing an entire aorta operation during a single procedure.
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Material and methods |
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Mean diameter of the ascending aorta and aortic arch was 6.5 ± 1.2 cm (range, 4 to 10 cm). Mean left ventricular ejection fraction was 58.5% ± 9.9% (range, 15% to 70%).
Minimally invasive operations were performed in 7 patients (7.4%) and 5 of these were reoperative cases. In 9 patients, as part of a new indication for ETP, the ETP was performed as an adjunctive measure in preparation for the second operation, but would not have been done if cardiac disease did not warrant a prior mediastinal approach to deal with the cardiac problem. For these patients, with a normal aortic arch, the aortic arch was incised and the graft usually sewn into place beyond the left subclavian artery. The arch was then closed in two layers with a running 4 to 0 suture. The techniques for elephant trunk procedures have been described previously, including performing the anastomosis between the carotid and subclavian arteries [3, 4]. For patients with acute dissection, the aorta was transected and braced with an outer layer of felt. Anticoagulation postoperatively was not used unless indicated for other reasons such as for a mechanical valve; nor was glue used for anastomoses.
The elephant trunk was implanted proximally as an extension of the ascending aorta and aortic arch graft in 88% (83 of 94) of the patients. In 8.5% of patients (8 of 94) the graft was used for the aortic arch replacement with a distal elephant trunk, after previous ascending and hemiarch repairs. In 3 patients the anastomosis was performed distal to the left subclavian artery (3.2%, 3 of 94). In 15 patients, the distal anastomosis was performed between the left subclavian and common carotid arteries for the ETP [4]. While this is quicker, the disadvantage is that at the second operation, the left subclavian artery needs to be bypassed. Clearly, for the second-stage procedure, clamp time needs to be minimized to reduce the risk of spinal cord injury and attaching a bypass to the left subclavian artery ostium does take some time. To facilitate second-stage stent grafting, the distal portion of the elephant trunk was marked with metal clips and also a loop of metallic pacing wire so that this could be captured for subsequent stent grafting if needed.
Thirty-six (38.4%) patients underwent coronary artery bypass surgery and an aortic valve procedure was performed in 55 (58.5%). These aortic valve procedures included 20 aortic valve repairs or remodelings or reimplantations, 16 composite valve grafts, and 19 separate aortic valve replacements. One patient had a concurrent Dor procedure for poor left ventricular function, aneurysmal dilatation, and cardiomyopathy. Procedures undergone simultaneously with aorta surgery are listed in Table 2.
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In 64 of 94 (68%) patients, we used retrograde brain perfusion protection, which was run continuously throughout the period of circulatory arrest. In patients who had retrograde brain perfusion, the perfusion pressure was kept at approximately 25 mm Hg with a flow rate of about 500 mL per minute [5]. The average retrograde brain perfusion time was 37.5 minutes. In 15 of 94 (16%) patients, we used antegrade brain perfusion through the right subclavian artery with a side graft sewn onto the subclavian-axillary arteries and balloon occlusion of the innominate and carotid arteries with an average of 37.7 minutes of circulatory arrest. In patients having antegrade brain perfusion, the flow rate was approximately 10 mL · kg–1 · min–1 to maintain a pressure between 40 and 60 mm Hg [5]. For patients who underwent antegrade brain perfusion, the perfusion was used intermittently during circulatory arrest for a total of 50.3% ± 24.9% of the circulatory arrest period (range, 10% to 90%). In 15 (16%) of the 94 patients, profound circulatory arrest was used alone.
The average temperature for circulatory arrest on rectal temperature monitoring was 20.2° ± 4.1°C (range, 14.4° to 29.9°C), nasopharyngeal temperature, 14.4° ± 3.6° C (range, 8.9° to 23.5°C), bladder temperature, 20.1°C ± 3.9°C (range, 10° to 30.8°C), and blood temperature as measured by Swan-Ganz catheter, 13.9° ± 3.5°C (range, 7.5° to 24°C). The average cooling time for cardiopulmonary bypass was 40.0 ± 15.2 minutes (range, 17 to 108 minutes) and the average rewarming time, 80.3 ± 23.3 minutes (range, 31 to 140 minutes) for a total of 155.2 ± 47 minutes. The highest average blood temperature to which the patients were rewarmed measured by Swan-Ganz catheter was 37.3° ± 0.9° C (range, 35.4° to 39.5°C).
Statistics and follow-up
Data for these patients was gathered onto databases but were also extensively verified for this study. The data collection and analysis was approved for research by the Institutional Review Board (IRB). All patients operated at the Lahey Clinic who survived, underwent a second-stage elephant trunk procedure, except one patient who died before his second-stage operation.
Patients who underwent surgery at The Cleveland Clinic were all followed up by telephone calls and by contacting their physicians. These data were then used for the statistical analysis of timing of surgery and the hazards of delayed surgery. In addition, all patients who had not undergone second-stage procedures were followed up by IRB approved questionnaire. One patient, who had 1 to 2 years of follow-up after an operation performed in 1995, could not be contacted. In 16 of these patients, a prophylactic ETP had been performed and these patients were reevaluated. Furthermore, patients who had not had a second-stage procedure were contacted for evaluation for possibly undergoing a second-stage ETP.
Data analysis
The nonparametric estimates of time-related events were obtained by using the Kaplan-Meier method [6]. A parametric method was used to estimate the number of phases of instantaneous risk of death (hazard function) and to estimate its shaping factor [7]. Probability and hazard estimates are shown with 68% confidence limits (CL), equivalent to one standard error. Because of the low number of total events, multivariable analyses for predictors of death and stroke were not performed. The 30-day mortality is reported because, after 30 days, the patients increasingly underwent second-stage procedures with the risk of death from the second procedure.
Because death is a competing event to second-stage elephant trunk completion, the prevalence of second-stage completion was estimated using competing risks analysis [8, 9]. For this, three end-states were defined: (1) survival without second-stage completion (event-free survival), (2) second-stage completion, and (3) death before second-stage completion (for which patients were censored at the time of second-stage completion). Freedom from these endpoints was estimated by the multiple decrement product limit method described by Andersen and colleagues [10], with variances of these estimates based on the Greenwood formula. The instantaneous risk (hazard function), or transition rate, for each competing event was estimated by the parametric method described above for survival. Competing risks probability estimates (cumulative incidence function) were based on the individual hazard functions and used numeric integration.
The influence on survival of second-stage completion was obtained by conditional survival analysis as follows. Using the parametric model for the survival model for survival before second-stage completion, and an analysis of death following second-stage completion, a simulation was performed in which the second-stage completion was assumed to have occurred at various time intervals. Until the second-stage completion, patients were assumed to survive according to the curve for survival before second-stage completion, and then to follow the curve for survival after second-stage completion. We then ascertained the net conditional survival at five years.
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Results |
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Eleven patients died before the second-stage procedure; 2 from aortic rupture (descending and thoracoabdominal aorta diameters of 5 cm in the first patient , and 7 cm and 6.7 cm, respectively, in the second patient), 2 from cancer, 1 from asphyxia as a result of a mucous plug obstructing a tracheostomy site, 1 from bowel ischemia, 1 from pneumonia, and 4 from undocumented causes.
Forty-seven patients (50%) underwent second-stage procedures with a mean interval of 168 days; 40 by left-sided thoracoabdominal incisions and 7 by stent graft insertion. In open operations for second-stage repair, 20 of 40 patients (50%) had descending aortic graft replacements and 20 patients (50%) had thoracoabdominal aortic replacements.
In all the second-stage operations, we used the adjuncts of distal aorta perfusion and perioperative cerebrospinal fluid drainage. Aortic clamp times ranged from 10 minutes to 162 minutes (mean, 53.9 ± 40 minutes). Pump times were 20 minutes to 269 minutes (mean, 122.4 ± 65.2 minutes). For the patients who underwent thoracotomy, atriofemoral bypass was used in 27 patients and femorofemoral cardiopulmonary bypass partial perfusion in 13 patients. Deep hypothermia and circulatory arrest was not used for second-stage procedures.
Five patients who underwent stent grafting had descending thoracic aneurysms and 2 had Crawford Type II thoracoabdominal aneurysms stenting with visceral bypass from a common iliac artery before stent grafting (Fig 1). These seven patients had significant medical comorbidities or left chest problems that made them inoperable by standard descending aortic or thoracoabdominal aneurysm techniques. Most of these patients were also elderly with six of the seven being more than 65 years of age.
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After the first-stage operative procedure, the five-year survival rate was 66% (as shown in Fig 2). Freedom from second-stage repair at 1, 3, and 5 years was 59%, 52%, and 49%, respectively (Fig 3A). The hazard function for second-stage repair, namely when most of the second-stage procedures were performed, peaked at about 4 months after repair and fell to a low level by one year (Fig 3B). To estimate the true prevalence of second-stage completion, interim deaths must be accounted for. Nine patients died before second-stage completion, 2 of rupture (Fig 4). Figure 5 shows the rates of transition to second-stage completion and death before this. Note that the highest risk of death occurred early after first-stage operation. The influence of these two competing risks is shown in Figure 5B. The figure depicts the cumulative incidence of patients remaining alive with first-stage elephant trunk repair, those going on to second-stage completion, and the competing risk of death before second-stage completion. With the strategies employed during this study, at 5 years 34% of patients were alive with first-stage repair, 45% had achieved second-stage completion, and 21% died before second-stage completion. All deaths observed after second-stage completion were within 7 months (Fig 6), and, thereafter, minimal out to 5 years with survivals of 86% at 30 days, 78% at 1 year, 76% at 3 years, and 75% at 5 years.
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Comment |
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In patients who underwent a second-stage procedure, the results were in keeping with expected survival rates with a 92% survival for the second-stage operation and a 4.3% incidence of spinal cord injury. In this series, no patients developed paralysis after the first-stage operation. In a previous report of 84 patients undergoing ETPs, 3 patients developed spinal cord injury after the first-stage procedure [3]. In these latter 3 patients, long elephant trunks had been inserted and it is believed that these occluded the intercostal arteries, resulting in leg paralysis after the first operation. Because of this, it was recommended that the distal elephant trunk graft should be no longer than 10 cm to 15 cm to reduce the risk of paralysis [3]. The present series of patients appears to confirm the safety of using a shorter elephant trunk graft. In addition, it is important to insure that both the true and false lumens are perfused in patients with chronic dissection. Of note, in a series of patients with acute dissection, when an elephant trunk type procedure was performed for their aortic dissections, Miyairi and colleagues [12] noted 21% of patients became paralyzed, confirming that in patients with small aortas, a long elephant trunk may occlude intercostal arteries and cause paralysis. In patients with large aneurysms, this is probably not as great a risk factor since clotting usually does not form around the entire elephant trunk, although it does form proximally in the descending aorta.
Prophylactic elephant trunk procedures were placed in 16 patients, usually in patients with aortic dissection but the aorta did not exceed 5 cm, with the plan that if a second-stage procedure was necessary, this would be easier to perform. Two of these patients later required a second-stage procedure that was facilitated by the elephant trunk graft. Since we would have expected more patients to have a second procedure, it is interesting to speculate as to whether the elephant trunk graft lying in the true lumen prevented further dilatation. We have noted that in some patients the graft becomes adherent to the wall of the true lumen and results in scar tissue forming around it.
In this series of patients, there were nine patients who required descending or thoracoabdominal aneurysm repairs that could have been performed without an adjunctive elephant trunk procedure if it had not been for cardiac comorbidity. In these patients, the cardiac pathology, such as aortic valve regurgitation, coronary artery disease, or mitral valve disease, was corrected at the same time as the insertion of an adjunctive elephant trunk either anchored in the aortic arch or beyond the left subclavian artery. This allowed for the left internal mammary artery to be used for coronary artery bypass surgery since both the aortic arch and the left subclavian artery would not need to be clamped during the second-stage procedure. Furthermore, with an adjunctive elephant trunk in the proximal descending aorta, the descending aortic or thoracoabdominal aneurysm repair was simplified in that a proximal anastomosis would not need to be performed, and in many patients with descending aneurysms the distal elephant trunk needed only to be anchored distally in the descending aorta.
In this series, there were a number of patients who did not undergo second-stage operations. Ideally, all patients should undergo a second-stage procedure if they did not have prophylactic insertion of the elephant trunk during the first operation. In the study by Schepens and colleagues [13], 52% of patients underwent a second-stage operation and in the study by Safi and colleagues [14], 56% underwent a second-stage operation. In a previous report of 84 patients [3], 56 (67%) underwent a second-stage operation. This raises the issue of whether doing a much more extensive single-stage operation [15] with both mediastinal and thoracoabdominal incisions is warranted in these patients. Although we have replaced the entire thoracic aorta or the entire aorta using both mediastinal and thoracoabdominal incisions [13], the mortality rate for this has been 17%. All patients, with the exception of one patient who only required five days of ventilation support, required at least two weeks of ventilation support after the operation. This, however, must be compared and balanced against the risk of death from the first-stage ETP, death within the intervening period between the first-stage and second-stage operations, and death after the second-stage operation. Clearly, analysis of this problem is complex and only a prospective randomized study would answer the question as to which is the best approach, although this will probably not be done.
We attempted to analyze the hazards of the competing risks on survival, namely, having a second-stage procedure and the risk of death with delayed second-stage surgery. This analysis is complicated by the fact that a second-stage operation would probably only prevent deaths related to rupture and not the deaths related to complications from the first procedure or other intervening causes of death. The hazard function clearly shows that the risk of death is highest early after the first-stage operation. This is in keeping with the previous report of the risk of rupture during the early period after surgery [3] and also the known risk of early rupture of abdominal aortic aneurysms after coronary artery bypass surgery. The latter typically occurs within the first two weeks after coronary artery bypass surgery, in patients with abdominal aortic aneurysms. Nevertheless, in many of these patients an early second-stage operation would not be tolerated. Alternatively, an earlier second-stage elephant trunk stent graft procedure may be a consideration [16]. Because of the risk of early death, potentially from rupture, we now make a determination before discharge as to whether patients should have an early stent graft procedure, sometimes even before discharge, or will tolerate an open procedure after a shorter period of recovery.
Subsequent to these data being collected, further patients have undergone elephant trunk procedures for a total of 142 first-stage procedures. In two of these patients the left subclavian artery occluded after completing the anastomosis between the carotid and subclavian arteries. One needed a carotid-subclavian bypass 5 months later at the time of stenting for the second stage and the other patient had no symptoms related to the occlusion and thus, at the second stage open repair, the subclavian artery was not bypassed.
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DR SVENSSON: That is a very good question, Dr Sundt, and I think, as you indicate, you have to be careful in patients with a small lumen in the descending aorta. We have carefully placed a short graft in the true lumen, but we have also in some patients gone ahead and put stents in the descending aorta to try to improve flow. It is important with chronic dissections to perfuse both the true and the false lumen, particularly because the risk of paralysis I think is greater if you try to perfuse just the true lumen.
As far as the broader question, are there patients in whom you wouldn't use the elephant trunk procedure, clearly in patients with symptomatic descending or thoracoabdominal aneurysms and also ascending disease, I think if you can just do the descending or thoracoabdominal, that is one approach. However, if you have to do both the ascending arch and also the thoracoabdominal aorta all at once, and if you cannot do the elephant trunk because of a big aneurysm, the option we have used is to do it all in a one-stage procedure using a mediastinal and thoracoabdominal incision. We have realized this carries a fair amount of morbidity, so we prefer the elephant trunk procedure whenever feasible.
DR SUNDT: And in the latter case, the case where you are doing the ascending arch and descending thoracic aorta, you do it through a two-incision approach rather than a clamshell as Dr Kouchoukos has advocated? What is your feeling on that?
DR SVENSSON: The reason for using both the mediastinal and thoracoabdominal incision in those patients would be patients where you need to get at the aortic root or you are doing coronary artery bypass surgery at the same time. We have used a minimally invasive J incision for some of those patients, too. I think one could use either method if it is mainly the arch. In some patients, we will often just use a thoracoabdominal incision with deep hypothermia and circulatory arrest and approach the aorta through the left chest. One trick that I learned from Marko Turina in those patients is just to divide the pulmonary artery, and that will often give you enough exposure to get down to the sinotubular ridge.
DR NICHOLAS T. KOUCHOUKOS (St. Louis, MO): Dr Svensson, several of the large series evaluating the elephant trunk procedure have shown a not insignificant incidence of rupture of the aorta between the first operation and the second operation. You, I believe, described two cases, and you have four cases of sudden death or death where the cause was indeterminate. Do you have any concern about anastomosing the elephant trunk to a dilated aorta at the site of the anastomosis and the potential for the aorta to rupture or for that suture line to separate?
DR SVENSSON: That is a very good question, Dr Kouchoukos, and as you know from the earlier series that we reported back in 1989, that was a problem. So that is one of the reasons why we have gone to doing the anastomosis between the carotid and subclavian artery more often so we don't tailor down the aorta as much as we used to. That means you do have to then hook up the subclavian at the second-stage operation.
The other thing that I do is I put in a couple of extra interrupted pledgeted sutures to further strengthen the distal anastomosis. If I am particulary worried about early rupture, I will go ahead and do the second stage early either open or increasingly with stent grafts. What we do at the first operation is we put metal markers on the end of the elephant trunk and a pacing wire to facilitate the second stage stenting. That means that when we come in through the groin for the second stage and hook that pacing wire, we pull it taut, and complete the second stage quite easily with a stent graft.
DR CAREY L. STOWE (Orlando, FL): Dr Svensson, I think this is also a wonderful operation, but where I run into problems sometimes is use of the elephant trunk in the acute aortic dissection. The tissues usually in the area of the subclavian may not be very strong to hold suture material. Do you have any tricks for using this in the acute dissection?
DR SVENSSON: We try to avoid doing elephant trunk procedures during acute dissection repairs because the tissues are very fragile. We will on occasion repair the tear in the aortic arch with a two-layer running suture. However, when you do have no other option, there are two ways that I have done the elephant trunk procedure.
One is to transect the aorta completely beyond the subclavian artery and put felt on the outside and then sew the inverted graft into position, with the felt buttress, with an over and over suture. I will put in additional sutures there just to make it water tight.
The other is to go a bit further down on the descending aorta, and you can go to just a bit behind the hilum of the lung, and in that area once again transect the aorta. I then parachute down the graft with pledgeted horizontal mattress sutures like you would do for an aortic valve replacement. This is followed by a running over and over suture line along the doubled over aortic graft. However, these are difficult cases; there is no doubt about it.
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L. G. Svensson and E. R. Rodriguez Aortic Organ Disease Epidemic, and Why Do Balloons Pop? Circulation, August 23, 2005; 112(8): 1082 - 1084. [Full Text] [PDF]
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) represents a death and vertical bars represent asymmetric 68% confidence limits equivalent to 1 standard error (dashed lines). Numbers in parentheses are patients remaining at risk. The solid line is the parametric survival estimate enclosed within 68% confidence limits (dashed lines). (B) Instantaneous risk of death (hazard function).
