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a Department of Cardiothoracic Surgery, Mount Sinai School of Medicine, New York, NY, USA
b Department of Anesthesiology, Mount Sinai School of Medicine, New York, NY, USA
Received 29 November 2007; received in revised form 3 April 2008; accepted 8 April 2008.
* Corresponding author. Address: Department of Cardiothoracic Surgery, Mount Sinai School of Medicine, One Gustave L. Levy Place, PO-Box: 1028, New York, NY 10029, USA. Tel.: +1 212 659 6800; fax: +1 212 659 6818. (Email: christian.etz{at}mountsinai.org).
| Abstract |
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5 cm) or dissections requiring complete repair. Seventy-six pts (35%), group CS (close surveillance; median age: 68; 20–87 years), had less severe distal dilatation (Ø
5 cm), and had close follow-up after ET rather than planned distal repair. Results: Hospital mortality in group PC pts (descending Ø: 6.2 ± 1.2 cm) was 6.5% (9/139) following ET. In group CS pts (descending Ø: 4.1 ± 0.7 cm), hospital mortality after ET was 5.3% (4/76); 4.7% (10/215) had strokes but survived. Eighty-six percent (112/130) of group PC pts who survived proximal repair returned for planned surgical (101) or endovascular (11) completion after a median of 56 (0–2189) days. Hospital mortality for distal repair was 7.5% (9/120); two ET stage two pts (2%) developed paraplegia. Eighty-nine percent (16/18; descending Ø: 6.9 ± 1.0 cm) of group PC pts who did not undergo planned completion died a median of 5.4 (1.2–91.1) months after ET stage one. Overall cumulative survival in group PC, which includes pts dying before or without stage two, was 69% after 1, and 55% after 5 years. Survival in group CS pts was 88% at 1, and 57% at 5 years. Eight pts in group CS subsequently underwent distal repair, but 22/76 (29%) group CS pts who survived ET stage one died during follow-up despite surveillance. Conclusions: The low mortality after stage one justifies liberal use of the ET technique to facilitate future open or endovascular TA repair of the distal aorta. The 5-year cumulative mortality curves, however, suggest that staged repair of extensive TA is superior to one-step repair only if stage two can be done before rupture occurs. If one-step repair is possible, it may be preferable.
Key Words: Elephant trunk Aortic arch repair Descending/thoracoabdominal aortic aneurysm repair (TAAA) Intention to treat
| 1. Introduction |
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The elephant trunk technique was initially introduced by Hans Borst in 1983 as a means of simplifying repair of descending aortic aneurysms, and it has been widely adopted [1]. It involves incorporation of a graft during the distal anastomosis of complete arch replacement which is left dangling in the descending aorta, giving it the appearance of an elephant's trunk. The dangling graft segment can be grasped from below during subsequent open DTA repair, providing a secure proximal anastomosis, and is also a good place to seat an endograft. Because of the ease of its use, and the recognition that aneurysmal disease may eventually extend to the entire aorta, the ET is often placed during arch surgery even in patients with no apparent immediate need for descending aortic repair.
In this retrospective report, we analyze the results in two groups of patients. In group PC (planned completion) are patients who have aneurysmal disease extending into the descending aorta in which the elephant trunk is the first stage of planned two-stage approach. This group is further analyzed to evaluate the results in those who completed the two-stage procedure and those who failed to return for the second stage. Group CS (close surveillance) comprises patients in whom the ET was placed with no immediate plans for further surgery or endovascular intervention.
| 2. Materials and methods |
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2.1 Patient grouping by intention to treat
We divided the patients into two groups determined by the plan of treatment prior to the first operation. Group PC included those patients in whom a two-stage treatment of extensive aneurysm was planned from the outset: this is the only group it seems legitimate to compare with patients who undergo single-stage extensive aneurysm repair. Nevertheless, we were also curious as to the outcome of patients who underwent ET repair even though the descending aorta at the time of ascending aorta/arch operation did not require immediate treatment (group CS).
The 139 patients in group PC had a median age of 68 (28–86 years) and had extensive DTA (
5 cm; median diameter of 6.2 cm) or dissections requiring complete repair. In this group, total arch replacement using the elephant trunk technique (ET 1) was planned to be followed by subsequent ET completion. Risk factors in this group, as seen in Table 1
, were hypertension in 104, COPD or asthma in 14, diabetes in 8, and renal insufficiency in 4, requiring preoperative hemodialysis in one. Eight patients presented with Marfan syndrome (Table 1).
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5 cm): a median descending aortic diameter of 4.2 cm. Patients in this group had close follow-up after ET rather than planned distal repair. Further clinical characteristics and preoperative risk factors are also shown in Table 1. There was not a significant association between etiology and treatment group (p = 0.15). The most frequent indication for aortic arch replacement (Table 2 ) was a chronic or acute dissection (Stanford type A) in 80 patients (37%); 76 patients had an atherosclerotic aneurysm (35%); 6 patients had a penetrating atherosclerotic ulcer (3%), and 12 patients had other pathologic conditions (Table 2). Among the differences between the groups were a slightly higher proportion of dissections in group PC patients, and a significantly higher proportion of patients with preoperative and intraoperative evidence of atheromatous disease in group CS.
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2.2.2 Hypothermic circulatory arrest (HCA)
Hypothermic circulatory arrest was effected by surface (cooling blanket) and perfusion cooling. If HCA was anticipated early in the procedure, the patient was cooled during the initial period of cardiopulmonary bypass. A minimum of 30 min of cooling was utilized. In some patients in whom HCA occurred later in the operative procedure, the patient was maintained at a perfusion temperature of 20 °C until about 15 min before HCA, after which the blood temperature was lowered to 10 °C. Adequate cerebral cooling was assured in all cases by a jugular venous saturation >95% and an esophageal temperature of 12–15 °C. In all patients in whom >20 min of HCA was anticipated or selective cerebral perfusion was utilized, the head was packed circumferentially in ice.
Perfusion warming was carried out at the end of the procedure with the gradient between the esophageal and blood temperature maintained <10 °C. Warming was maintained until esophageal temperature reached 35 °C, and bladder temperature was >32 °C. Downward drift, however, resulted in most patients leaving the operating room at esophageal and bladder temperatures of 32 °C. Warming was usually accomplished in 1 h of perfusion; during the last 15 or 20 min, partial bypass was frequently utilized to take advantage of improved warming with pulsatile perfusion.
2.2.3 Selective cerebral perfusion (SCP)
Perfusion of all three head vessels was achieved during selective cerebral perfusion. In the early portion of this series, SCP was provided by suturing an island of arch tissue to a beveled 16–18 mm Hemashield graft, and providing inflow either via the graft or via the right axillary artery. Once the use of the trifurcation graft was introduced for arch repair, SCP was provided by providing inflow to the trifurcation graft via the right axillary artery [2–5]. SCP was carried out at a blood temperature of 15–20 °C, and flow sufficient to maintain a pressure of 50–60 mmHg. This usually required a flow of 800–1200 cc/min. The average duration of SCP was 66 ± 24 min, and ranged from 20 to 143 min.
2.2.4 Arch replacement with first stage elephant trunk repair
Arch replacement was carried out by suturing the head vessels to a beveled or a trifurcation graft. The details of the surgical technique have previously been described [5]. Briefly, reconstruction is approached through a median sternotomy, but can be performed using a bilateral anterior thoracotomy. The proximal aortic root reconstruction is performed while cooling, slowly lowering core temperature toward 15 °C. The ascending aorta cross-clamp is applied if significant aortic valve insufficiency is present or if direct epi-aortic scanning (12 MHz) confirms minimal intraluminal clot or atheroma. If a jugular bulb catheter is available, a saturation >95% indicates maximum cerebral metabolic suppression. A custom trifurcated graft may be constructed, or a commercially prepared graft is utilized (Boston Scientific, Natick, MA).
During circulatory arrest, the brachiocephalic vessels are transected approximately 1 cm beyond their origins; the presence of macroscopic atherosclerotic disease may warrant further resection. The arch vessels are serially anastomosed with 5-0 polypropylene sutures. Typically the left subclavian artery is attached first, followed by the left common carotid and innominate arteries. Each limb is gently aspirated and, clamping the main limb of the trifurcated graft, axillary perfusion is resumed, providing hypothermic SCP to the head and upper extremities. The perfusate temperature is allowed to drift upward during the remaining arch repair; no active rewarming is begun until full systemic flow is resumed. With the trifurcated graft reflected superiorly, providing unimpeded access to the upper mediastinum, a suitable site for the elephant trunk anastomosis is created. When appropriate, the brachiocephalic arterial stumps are oversewn as necessary, and the elephant trunk anastomosis is constructed proximal to the left subclavian artery, which is technically easier, and avoids injury to the left recurrent laryngeal nerve. A second Dacron graft is inverted within itself and placed within the descending thoracic aorta. The proximal elephant trunk anastomosis is then carried out with a Teflon felt on the inside and the graft on the outside. The proximal portion of the graft is then withdrawn from the descending thoracic aorta, allowing free flow into the distal aorta.
A graft-to-graft anastomosis is then constructed between the elephant trunk graft and the proximal repair, and these grafts are distended to facilitate choosing the ideal site for anastomosing the trifurcated graft. An opening is fashioned and the beveled end of the trifurcated graft is anastomosed without interrupting cerebral circulation. With the grafts de-aired, the clamp is removed, restoring myocardial and distal body perfusion, and rewarming is begun (Fig. 1).
2.3 Distal repair
2.3.1 Cannulation and distal aortic perfusion
Extracorporeal circulation was established either via left atrial-to-femoral bypass or partial femoro-femoral bypass with an in-line oxygenator and distal aortic perfusion.
2.3.2 CSF drainage
A catheter for drainage of cerebrospinal fluid was placed routinely and cerebrospinal fluid was drained at a maximum rate of 15 cc/h as long as cerebrospinal fluid pressure remained above 10 mmHg. Cerebrospinal fluid drainage was continued in most patients for 48–72 h postoperatively as previously described [6].
2.3.3 SSEP and MEP monitoring
Somatosensory evoked potentials (SSEP) have been monitored since 1993, and motor-evoked potentials (MEP) since 2002, during descending thoracic and thoracoabdominal aortic aneurysm repair on a routine basis, as previously described [7–9].
2.3.4 Second stage elephant trunk repair
The aorta is accessed through a left thoracotomy or thoracoabdominal incision. The diaphragm is divided circumferentially. The infradiaphragmatic aorta is exposed through a retroperitoneal approach. All operations are carried out under at least moderately hypothermic conditions (32 °C).
The aneurysm is dissected free from mediastinal tissue. The intercostal and lumbar arteries are dissected and temporarily occluded. If MEP and SSEP remain unchanged, the segmental vessels are sacrificed before opening the aneurysm to avoid backbleeding and possible steal from the spinal cord circulation. This technique has previously been described in detail [8,9].
For the visceral segment, a beveled anastomosis is frequently utilized. If the visceral segment must be replaced circumferentially, the visceral vessels are occluded with a balloon catheter and intermittently perfused with cold blood before they are directly anastomosed to the graft or connected utilizing intervening graft segments (8–12 mm Dacron).
Vascular Dacron grafts (Hemashield; Boston Scientific, Natick, MA; 18–32 mm) with as many as three additional side arms were implanted in an end-to-end fashion.
2.4 Postoperative management after second stage ET
Somatosensory evoked potentials are monitored until the patient awakens. Thereafter, hourly brief neurologic examinations are performed for 72 h. High normal blood pressures are maintained, aiming for an aortic mean pressure of 80 mmHg. Cerebrospinal fluid drainage is continued for 72 h, and steroids are tapered over 48 h as previously described [6].
2.5 Follow-up
All patients were followed by the referring cardiologist and contacted periodically by our research personnel. Postoperative events were compiled and analyzed according to the guidelines for reporting morbidity and mortality after cardiac valvular operations [10] and our institutional checklist.
2.6 Statistical methods
Data were entered in an Excel (Microsoft Corp, Redmond, Washington) spreadsheet and transferred to a SAS file (SAS Institute, Cary, North Carolina) for data analysis. Patient characteristics are described as percents and range or means and standard deviations. Groups were compared using chi-square tests, t-tests or Wilcoxon tests, as appropriate. Early death is defined as death within 30 days after the procedure or death before discharge, if beyond 30 days. Risk factors were compared between groups using chi-square tests, t-tests or Wilcoxon tests, as appropriate. Kaplan–Meier survival curves were estimated to describe early- and long-term survival, and logistic regression analysis was used to find factors associated with failure of the staged repair approach.
| 3. Results |
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Eight patients in group CS ultimately had a stage two procedure, as might have been anticipated: they should not be considered failures of the close surveillance strategy. We examined the overall long-term survival in group CS patients, and looked closely at those who died during follow-up to try to determine how many of these patients might have benefited from earlier resection of their distal aneurysms.
Follow-up was complete in all patients with regard to mortality, although the specific cause of death could not always be established with certainty.
3.1 Comparability of groups
Testing for differences between group PC and group CS patients in demographic and risk factor distribution at the time of stage one repair revealed no statistically significant differences in gender, age, hypertension, non-insulin depending diabetes mellitus (NIDDM), chronic renal insufficiency, COPD or asthma, urgency of the procedure, Marfan syndrome, reoperative procedure, previous paraplegia or hemodialysis (Table 1), or concomitant CABG (Table 3
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3.2 Hospital mortality after ET stage one
There was no statistically significant difference between the hospital mortality, defined as death in the hospital or within 30 days postoperatively, after stage one elephant trunk repair between the groups (p
= 0.72). In group PC patients, those slated for complete repair, hospital mortality was 6.5% (9/139) following stage one ET procedures. In group CS patients, hospital mortality after ET stage one was 5.2% (4/76).
3.3 Postoperative complications after ET stage one
The overall stroke rate after ET stage one was 6.0% (13/215), three of which led to early death. Group PC patients were significantly less likely to suffer postoperative stroke after ET stage one, 2.9% (4/139), as compared with 11.8% (9/76) in group CS patients (p
< 0.01). Among patients who did not suffer a stroke, the worst complications (permanent hemodialysis, tracheostomy, postoperative bleeding) and others (respiratory failure, renal failure, temporary neurological deficit and arrhythmia) did not differ significantly between groups (p
= 0.90, Table 4
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3.5 Interval loss prior to ET stage two in group PC
Eighty-six percent (112/130) of group PC patients survived proximal repair and returned for planned surgical or endovascular completion after a median of 56 (0–2184) days; eight additional CS group patients returned for ET stage two during close surveillance. Fourteen percent (18/130) of ET stage one survivors, all operated on electively, did not return for planned completion repair after hospital discharge. In one patient, attempted ET stage two was abandoned because of extensive adhesions.
The median age at ET stage one among the 18 non-returnees was 74 (range 46–82 years), higher than among patients who did return for planned completion repair. Non-returnees more frequently had atherosclerotic aneurysms, 65%, than group PC patients in general (38%), with a slightly larger descending diameter (6.9 ± 1.0 cm) than in group PC as a whole, but similar arch dimensions (6.7 ± 2.1 cm).
Eight non-returnees (8/18, 44%) had a complicated postoperative course after the first stage of repair: respiratory failure requiring tracheostomy occurred in six cases, and at least one other major complication, bleeding or dialysis, occurred in two. Forty-four percent (8/18) of non-returnees had also undergone concomitant CABG as part of their previous stage one repair.
Sixteen of 18 (89%) patients who did not return for completion repair died at a median of 4 (1–91) months after ET stage one. Seven patients (39%) died within 4 months after ET stage one; six between 4 and 24 months, one after 38 months, and two after 5 years. Only two patients, with descending aortic diameters of 5.8 and 7.8 cm, respectively, were alive at 27 and 83 months after ET stage one without completion repair.
The causes of death within the first 4 months (7 pts, median interval after ET stage one, 97 [36–106] days) were chiefly related to untreated descending aortic aneurysmal disease. The median descending aortic diameter of the seven patients that died within 4 months after ET stage one was 7.7 cm (5.4–9.1 cm): 57% (4/7) died of a ruptured descending aneurysm. One patient had a stroke, and in two patients the cause of death is not known (descending diameters were 5.4 and 6.0 cm).
Among the six patients that died between 4 and 24 months after ET stage one, five had atherosclerotic disease. Three of them had descending diameters ranging from 6.4 to 7.1 cm and died of unknown causes. In three patients, death was most likely unrelated to aneurysm disease: one died of cardiac causes; one suffered from acute intestinal occlusion, and another from sepsis, albeit with subsequent graft infection.
Thereafter, late mortality (>24 months) occurred in three patients (19%): one (descending aortic diameter: 5.9 cm) died of cardiac disease and two patients (with descending aortic diameters of 6.7 and 7.0 cm) ultimately died of unknown causes.
3.6 Hospital mortality and postoperative complications after ET stage two in group PC
Hospital mortality for distal repair was 7.5% (9/120). Four patients had lethal neurological complications; sepsis occurred in three; rupture of an infrarenal aneurysm in one, and multi-organ failure in one. Among these hospital deaths, etiology was dissection in five patients, degenerative aortic aneurysm in two, and atherosclerotic aneurysm in two. Two patients (1.6%) developed paraplegia. Postoperative complications after completion repair are listed in detail in Table 5
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3.8 Long-term mortality after ET stage one and ET stage two in group PC
In group PC (n
= 139), 112 ET stage one survivors (81%) underwent completion repair after a median of 56 (0–2184) days; 16 of the remaining 18 ET stage one survivors died before or without stage two after a median of 165 (37–2773) days, and 2 patients were alive at 829 and 2510 days after ET stage one. Overall survival in group PC was therefore 69% after 1, and 55% after 5 years.
One year after ET stage one, when the majority of group PC patients had undergone completion repair (ET stage two) the long-term survival appears to be equivalent to that of a normal age and sex matched population (Fig. 2 ).
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Independent risk factors associated with death prior to successful completion repair (discharge after stage two) were: age at ET stage one (p = 0.047); descending diameter (p = 0.003), and concomitant CABG (p = 0.008). (Stepwise logistic regression odds ratios were: 1.05/year for age, 1.80/cm for descending diameter, and 3.4 for concomitant CABG.)
3.10 Survival in group CS after ET stage one
Survival in group CS patients, those without planned completion repair, was 88% at 1, but 57% at 5 years. Eight patients subsequently underwent distal repair (11%) after a median interval of 12 (1–85) months, but 30% of group CS patients died despite surveillance.
Among these 23 patients, who had a median age of 72 years (not significantly older than group CS in general), the mean descending aortic diameter was 4.7 ± 0.8 cm, only slightly greater than in group CS as a whole, as was the diameter of the arch prior to stage one ET (6.6 ± 1.4 cm). Four had undergone urgent (2) or emergent (2) ET stage one procedures. Eleven of the patients (48%) had atherosclerotic aneurysm disease: this is slightly more than the frequency of atherosclerotic aneurysms in group CS in general. Chronic dissection was the underlying etiology in only four (17%) deaths (vs a 30% incidence in group CS as a whole); eight patients had degenerative or other etiologies.
Three patients died within 3 months after ET stage one: one of traumatic hemorrhage on coumadin, and two never fully recovered from postoperative stroke. Two patients with respiratory failure died within 1 year after ET stage one. Six patients (with a median descending diameter at surgery of 4.8 cm, range 3.9–5.8) eventually died of unknown causes (one was on chronic hemodialysis), and one died after emergent surgery of an unknown nature.
| 4. Discussion |
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In order to evaluate the success of the two-stage approach to patients in group PC, it seems reasonable to take into account not only the mortality and complications for each of the two operations, but also the results in those who rupture their aneurysms before completion of stage two of the planned repair. In our series, the rate of return of patients with planned stage two repair was very high. But of the 18 patients who failed to complete ET stage two, at least 4 died of aneurysm rupture, and in another 4 the cause of death is not known. Half of the known rupture-related deaths occurred within the first three months after surgery, making it tempting to speculate that a shorter interval between the two stages or a single-stage repair might have produced a better outcome. However, a majority of the patients failing to return for reoperation had suffered major complications following stage one of the elephant trunk repair, chiefly respiratory failure. This suggests that at least some of the patients who never reached stage two would likely not have survived either a more extensive single-stage repair, or earlier scheduling of the second stage. The view that it is intrinsic patient characteristics which determine whether a two-stage ET strategy will be successful is confirmed by the analysis of the risk factors for failure of the two-stage strategy: increasing age, a larger descending aortic diameter, and concomitant CABG (implying presence of significant coronary artery disease).
A review of the recent literature, Table 6 , suggests that most other aneurysm surgeons encounter at least as high and sometimes a much higher rate of attrition between the stages of a planned two-stage elephant trunk repair. In some cases, judging from the intervals between first and second stages, the apparent high rate of failure to return for stage two likely reflects inclusion of patients whom we have classified as group CS: those not requiring immediate distal repair. Safi et al. have concluded that to avoid loss of patients in the interval between stages, the optimal timing of the second stage should be between 4 and 6 weeks after stage one ET [15].
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The prevalence of major cardiorespiratory and renal morbidity among patients with extensive aneurysms at risk of rupture underlines the need for developing endovascular strategies for their repair. Analysis of risk factors for death before completion of the two-stage operation reveals age and need for concomitant CABG as significant independent predictors, in addition to the diameter of the descending aorta. If most ET stage two procedures could be carried out endovascularly, there would be much less need to wait more than a few days after the arch procedure to complete the repair. This would be a major step forward in improving long-term outcome after a stage one elephant trunk repair, especially the tragic death from aneurysm rupture of individuals before the second stage of a two-stage process. Endovascular repair would also likely significantly reduce the morbidity and mortality of stage two, and be less daunting to patients, encouraging their return. We are reluctant to endorse routine open endovascular completion at the time of ET stage one for patients with extensive aneurysms because we feel this may enhance the chance of developing paraplegia; paraparesis occurred in the one patient in whom the combined procedures were carried out concurrently.
In general, the long-term outcome in patients in group CS is not as encouraging as one might have hoped. We subjected to special scrutiny group CS patients who died from a ruptured aneurysm during follow-up after ET stage one despite close surveillance. Analysis of these patients revealed that several had undergone ET stage one under urgent or emergent conditions, possibly precluding a careful weighing of optimal long-term surgical strategy. A greater proportion of CS than of PC patients had atherosclerotic aneurysms and a history of cerebrovascular accidents, and several of the patients who died relatively early after ET stage one suffered postoperative strokes, respiratory failure or other long-lasting complications from which they never fully recovered. Thus, in a substantial proportion of CS patients with poor outcomes, failure of adequate surveillance of the distal aorta is probably not to blame for their deaths.
Nevertheless, nearly half of the long-term deaths in patients surviving ET stage one without planned future intervention are unexplained, and some of these are likely to have been due to rupture of the distal aorta. This suggests that more frequent and/or more detailed follow-up may be important for patients following stage one ET repair even when the distal aorta is not severely dilated at the time of surgery.
| 5. Conclusion |
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| Appendix A |
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Dr M. Turina (Zurich, Switzerland): You have alluded, of course, to the impact of the endovascular procedures which are ideally suited now to complement the primary elephant trunk.
How many of the patients in your group underwent endovascular treatment?
Dr Etz: It was a total of twelve patients. Another 14 have been done subsequent to this review.
Dr T. Orszulak (Rochester, Minnesota): In the group that did not return, was their death due to interval rupture or was it due to comorbidities from the first operation, renal failure, et cetera?
Dr Etz: Both, actually. Almost half of the patients did not return during the first 4 months after ET 1 because of ongoing disability dating from the first operation.
There were also four known ruptures within 4 months after ET 1, and an additional two patients who died of unknown causes during that interval. The median diameter of the descending aorta in the patients who died within 4 months after ET 1 was 7.7 cm. We absolutely believe that a shorter interval between stages would be preferable for patients with really large aneurysms.
Dr Turina: Just a last very quick question. How come COPD does not enter the calculation anymore?
Dr Etz: In a multivariable equation for rupture risk, we have previously shown that COPD is an important independent predictor. In our experience, however, COPD has been less powerful as a predictor of operative risk in aortic surgery. In this series, COPD was a univariate predictor of death, but it did not retain significance in the multivariable analysis.
| Footnotes |
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Presented at the 21st Annual Meeting of the European Association for Cardio-thoracic Surgery, Geneva, Switzerland, September 16–19, 2007. | References |
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