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Surgical Treatment for Thoracic Aneurysms: Comparison of Stent Grafting and Open Surgery

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Objectives: Early and mid-term results of stent graft (SG) treatment for thoracic aortic aneurysms (thoracic endovascular aneurysm repair: TEVAR) were retrospectively compared with open surgical treatment. Methods: The records of 213 patients in whom single thoracic aortic aneurysm repairs had been performed in our department from January 2006 through August 31, 2009 were reviewed. Acute aortic dissection was excluded. Each case was reviewed for indications for TEVAR from an anatomical standpoint. Among 62 cases in which TEVAR was indicated, 30 (SG group) were treated by TEVAR and 32, by open surgery (OP group). Early and mid-term results were analyzed retrospectively in both groups. Results: There were no operative deaths in either group. The SG group demonstrated significantly less operative bleeding, a shorter operative time, and shorter postoperative hospital stay compared with the OP group. There were 3 deaths in the SG group and 4 in the OP group, which occurred within an average of 656.4 days during the follow up period. The 3 year actuarial survival rate was 88.7% in the SG group and 87.1% in the OP group, and there were no significant differences between the groups. Conclusion: Although early and mid-term results of TEVAR and open surgery were similar, TEVAR is generally less invasive and may be preferable for high-risk patients, compared with open surgical repair. (English Translation of Jpn J Vasc Surg 2010; 19: 51-56.).
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15
Annals of Vascular Diseases Vol.5, No.1 (2012)
Original Article
Surgical Treatment for Thoracic Aneurysms:
Comparison of Stent Grafting and Open Surgery
Koichi Yuri, MD, Atsushi Yamaguchi, MD, PhD, Daijiro Hori, MD, Manabu Shiraishi, MD,
Hiroshi Nagano, MD, Atsushi Tamura, MD, Kenichiro Noguchi, MD, Kazuhiro Naito, MD,
Kazunari Nemoto, MD, and Hideo Adachi, MD, PhD
Objectives: Early and mid-term results of stent graft (SG) treatment for thoracic aortic aneurysms (thoracic
endovascular aneurysm repair: TEVAR) were retrospectively compared with open surgical treatment.
Methods: The records of 213 patients in whom single thoracic aortic aneurysm repairs had been performed
in our department from January 2006 through August 31, 2009 were reviewed. Acute aortic dissection
was excluded. Each case was reviewed for indications for TEVAR from an anatomical standpoint. Among
62 cases in which TEVAR was indicated, 30 (SG group) were treated by TEVAR and 32, by open surgery
(OP group). Early and mid-term results were analyzed retrospectively in both groups.
Results: There were no operative deaths in either group. The SG group demonstrated signicantly less
operative bleeding, a shorter operative time, and shorter postoperative hospital stay compared with the
OP group. There were 3 deaths in the SG group and 4 in the OP group, which occurred within an average
of 656.4 days during the follow up period. The 3 year actuarial survival rate was 88.7% in the SG group
and 87.1% in the OP group, and there were no signicant differences between the groups.
Conclusion: Although early and mid-term results of TEVAR and open surgery were similar, TEVAR is
generally less invasive and may be preferable for high-risk patients, compared with open surgical repair.
(English Translation of Jpn J Vasc Surg 2010; 19: 51-56.)
Keywords: thoracic aortic aneurysm, vascular surgery, endovascular surgery
IntroductIon
With advances in medical techniques in recent years,
surgical treatment for thoracic aneurysms has markedly
improved. The indications for surgery have expanded
to patients with complications and elderly patients, and
surgery has been actively performed. In 2008, com-
mercially available SG devices for thoracic aneurysms
began to be covered by insurance in Japan, and treatment
choices have increased. Therefore, the indications for
stent grafting (SG) for thoracic aneurysms are expected
to expand further.
Open surgery for thoracic aneurysms is an almost
established method. However, in many cases, its in-
vasiveness requiring thoracotomy and extracorporeal
circulation is a problem. On the other hand, since SG (tho-
racic endovascular aneurysm repair: TEVAR) is a new
treatment method, its long-term results are still unclear.
At present when there are many treatment choices, the
indications for both should be adequately considered, and
the most appropriate treatment strategy for each patient
should be selected. Although some studies have shown the
superiority of TEVAR, it is unclear whether open surgery
was selected for lesions strictly indicated for TEVAR.1, 2)
Department of Cardiovascular Surgery, Saitama Medical Cen-
ter, Jichi Medical University, Saitama, Saitama, Japan
Received: September 20, 2011; Accepted: December 6, 2011
Corresponding author: Koichi Yuri. Department of Cardiovascular
Surgery, Saitama Medical Center, Jichi Medical University, 1-847,
Amanuma-cho, Omiya-ku, Saitama, Saitama 330-0834, Japan
Tel: +81-48-647-2111, Fax: +81-48-645-0621
E-mail: kyuri@jichi.ac.jp
*This article is English Translation of Jpn J Vasc Surg 2010; 19:
51-56 .
Ann Vasc Dis Vol.5, No.1; 2012; pp15–20
©2012 Annals of Vascular Diseases doi: 10.3400/avd.oa.11.00920
Yuri K, et al.
16 Annals of Vascular Diseases Vol.5, No.1 (2012)
We retrospectively evaluated early and mid-term treat-
ment results in patients in whom both TEVAR and open
surgery could be anatomically selected, and compared
the two surgical methods.
SubjectS and MethodS
We performed a retrospective study in 213 cases with
a single thoracic aneurysm excluding acute aortic dissec-
tion, who were surgically treated in our hospital between
January, 2006 and August 31, 2009. All cases were classi-
ed according to the location of the lesion, and sizing of
the SG device was performed. SG was indicated in whom
the landing zone could be ≥15 mm from the left common
carotid artery on the proximal side and ≥15 mm from the
celiac artery on the distal side, the arterial diameter at the
landing zone was 20–38 mm, and excessive calcication
was absent. Of the 213 patients, 62 (29.1%) had indications
for SG in our center. When these patients were classied
according to the actually selected treatment, 30 patients
were classied as the TEVAR group (SG group) and the
other 32 as the open surgery group (OP group). The both
groups were retrospectively evaluated.
For TEVAR, the Tokyo Medical University (T.M.U.)
type SG device (Najuta, Kawasumi Laboratories, Tokyo)
was introduced in 2006, and a commercially available SG
device (TAG® W.L. Gore, USA) was introduced in Januar y
2008. Before the introduction of the commercially available
SG device, open surgery was the rst choice. After the in-
troduction of the SG device, SG was recommended as the
rst choice to high-risk patients such as those with many
comorbidities, but the surgical method was nally selected
by patients and their families with adequate, informed
consent. Preoperative respiratory disorders were dened
as those that require take-home oxygen therapy or treat-
ment for respiratory dysfunction on an outpatient basis.
Postoperative respiratory disorders were dened as those
that require controlled ventilation ≥72 hours after surgery.
All values are expressed as the mean plus standard
deviation, and statistical differences were analyzed us-
ing Student’s t-test and the χ2 test. The survival rate was
analyzed using the Kaplan-Meier and Log-rank methods.
P <0.05 was regarded as signicant.
reSultS
1. Patient background
The reasons for the selection of SG in the 30 cases in the
SG group are shown in Table 1. SG was selected due to
high risk in 21 cases (70%). The most frequent reason was
the patients’ wish, which was observed in 9 cases (30%).
These results did not always reect our selection criteria.
A T.M.U. type Najuta was used in 23 of the 30 cases
and a TAG® in 7. The proximal landing was further
than Zone 4 in 21 patients; the other 9 cases needed a
proximal landing zone from Zone 0 to Zone 3. In the
OP group, replacement of the descending aorta via left
thoracotomy was performed in 25 of 32 cases, and total
arch replacement using the median sternotomy, in 7. In all
cases in this group, extracorporeal circulation was used.
Four cases of descending aorta replacement performed
at a normal temperature and the other 17 cases were
performed under hypothermic circulatory arrest. In the
7 cases who underwent total arch replacement, the mini-
mum core temperature was 25°C, and distal circulatory
arrest/antegrade selective cerebral perfusion was used as
the standard procedure.
As shown in Table 2, there were no signicant dif-
ferences in the mean age, male/female ratio, presence/
absence of atherosclerosis risk factors, preoperative respi-
ratory dysfunction, emergency operation, or the history
of open heart surgery, between the SG and OP groups.
2. Early results
There were no operative deaths in either group, and
all cases in both groups were discharged on foot or
transferred to another hospital. Postoperative cerebral
infarction was observed in 3 cases in the OP group,
paresis in 2, in the SG group, and paraplegia in 1, in the
OP group. However, these conditions improved after
rehabilitation, and their incidence did not signicantly
differ between the two groups. The operation time, period
(days), until the initiation of postoperative oral intake, and
Table 1 Reasons for stent graft choice
Major specic indication Number %
Patient request 9 30.0
Advanced age 5 16.7
Cardiopulmonary disorder 4 13.3
Advanced age • post-thoracotomy 3 10.0
Central nerve disorder 3 10.0
Post-thoracotomy 2 6.7
Multiple a neurysms 2 6.7
Dialysis 1 3.3
Cancer 1 3.3
Stent Grafting and Open Surger y for Thoracic Aneurysms
17
Annals of Vascular Diseases Vol.5, No.1 (2012)
the postoperative hospital stay (days) were signicantly
shorter in the SG group, and the bleeding volume was
signicantly smaller in the SG group. The percentage
of blood transfusion and the incidence of postoperative
respiratory dysfunction were signicantly lower in the
SG group. Thus, the SG group was superior to the OP
group, in terms of early results (Table 3).
3. Mid-term results
During the follow-up period, for a mean of 656.4 w
547.8 days, 3 cases in the SG group and 4 in the OP group
died or dropped out, but no signicant differences were
observed between the two groups (P = 0.89). The 3 year
survival rate was 88.7% in the SG group and 87.1% in the
OP group (Fig. 1). The cause of death was pneumonia/
respiratory dysfunction in 2 cases, malignant tumors in 2,
multi-organ failure in 2, and hematemesis, resulting in
sudden death, in 1.
Events considered being associated with aneurysms
were observed in 1 case in the SG group. In the above pa-
tient who died of hematemesis, even though the aneurysm
at the original treatment site had decreased in size, a new
aneurysm formed central to the SG area and appeared
to have ruptured into the esophagus. The exact cause of
death was unclear, but infection of the SG device was
strongly suspected. In 2 patients in the SG group, Type
II endoleak persisted from immediately after the opera-
tion, and their courses have been strictly observed on an
outpatient basis despite no changes in the aneurysmal
diameter. There have been no cases undergoing open
surgery after TEVAR or additional TEVAR.
Table 2 Preoperative data
SG group (n = 30) OP group (n = 32) P value
Age (y.o.) 70.1w14.1 69.6w10.7 0.89
Gender (male: female) 25: 5 24: 8 0.41
Hypertension 12 15 0.92
Diabetes 4 5 0 .72
Chronic renal failure (Cr>1.5) 3 2 0.34
Chronic respiratory disorder 6 3 0.24
History of thoracotomy 5 4 0.64
Emergency 3 4 0.60
SG: stent graft; OP: open surgery
Table 3 Perioperative data and morbidity
SG group (n = 30) OP group (n = 32) P value
Replacement of the arch N/A 7
Replacement of the descending aorta N/A 25
Involvement of Zone 0–3 (+) 9 N/A
Involvement of Zone 0–3 (−) 21 N/A
Operative time (min) 198. 3w 87.9 413.1w121.9 <.0 01
Operative bleeding (ml) 154.2w167.48 1002 .3w89 5.1 <. 001
Blood transfusion (%) 3 (10. 0%) 19 (59.4%) <.001
Postoperative controlled ventilation (day) 1.0w0.0 3.41w3.9 0.016
Postoperative oral ingestion (day) 1.1w0 .4 6 .71w11.9 0.013
Cerebral infarction (%) 0 (0.0%) 3 (9. 3%) 0.051
Par apleg ia (%) 2 (6.6%) 2 (6.2%) 0.70
Postoperative hospital stay (day) 12 .4 w7.1 30.0 w2 6.1 <.001
Operative mort ality 0 0 N /A
SG: stent graft; OP: open surgery
Yuri K, et al.
18 Annals of Vascular Diseases Vol.5, No.1 (2012)
dIScuSSIon
In Japan, as SG devices for thoracic aneurysms, TA
(W.L. Gore, USA) and TALENT (Medtronic, USA) began
to be covered by insurance in 2008 and have been used
to the present. In addition, clinical trials on T.M.U. type
Najuta are in progress, in 11 institutions in Japan, and this
device is also expected to be covered by insurance in the
future. After the introduction of these devices, treatment
choices for thoracic aneurysms have increased. According
to the survey of the number of surgically treated cases
conducted by the Japanese Society for Vascular Surgery,
surgery for aneurysms in the descending aorta was
performed in 683 cases in scal year 2006, 922 cases in
2007, and 1214 cases in 2008, showing a marked increase.
Of 1214 cases, 682 (56.2%) were treated by TEVAR.
These values indicate the involvement of an increase in
the number of cases treated by TEVAR, and a rise in the
total number of surgically treated cases. However, the
number of cases treated by TEVAR has been increasing
without a general consensus regarding the relative merits
between open surgery and TEVAR and criteria for the
selection of treatment.
Some studies that compared the groups treated by
open surgery or TEVAR in other countries have shown
the superiority of TEVAR in short-mid-term results.1–3)
In Japan, a study, which compared the two methods us-
ing a home-made device for lesions located in the same
area, showed good early-mid-term results after both
open surgery and TEVAR, but a signicantly higher
mid-long-term incidence of aneurysm-related events after
T E VA R . 4) In this study, in the TEVAR group, the early
operative death rate was 2.5% (1 of 40 patients), but the
mid-term incidence of aneurysm-associated events that
occurred during 3 years was 17.9%, which was a high
rate, compared with conventional open surgery. Thus,
long-term follow-up is important even at present when
there are commercially available devices.
Although this was a retrospective study, the open
surgery and SG groups were very similar when the le-
sion localization and patient background were compared.
No operative death was observed in either group, and
early treatment results were favorable in both groups.
However, postoperative cerebral infarction was observed
in the open surgery group, but not in the SG group. In
addition, the SG group showed a signicantly smaller
bleeding volume, signicantly higher blood transfusion
rat e, and sig n i cant ly shor t e r posto p e r ative hosp ital st ay.
These results suggest that TEVAR is less invasive than
open surgery.
In this study, in the SG group, aneurysm-associated
death was observed mid-term after surgery, and Type II
leak persisted after TEVAR, in 2 cases, who have been
followed up to the present at the outpatient clinic, and
in 9 of 30 cases, the SG device was placed proximal to
Zone 3. In such cases, the proximal landing zone was
often short, due to the presence of branches in the cervi-
cal area compared with TEVAR distal to Zone 4 (Fig. 2).
Therefore, concerning the long-term results of TEVAR,
aneurysm-associated events should be carefully analyzed
by close follow-up.
The evaluation of 147 patients who underwent open
surgery for aneurysms in the aortic arch, in our institu-
tion, between 2000 and April 2008, showed no operative
Fig. 1 Kaplan-Meier Survival Curves for the each group.
Stent Grafting and Open Surger y for Thoracic Aneurysms
19
Annals of Vascular Diseases Vol.5, No.1 (2012)
death nor postoperative cerebral infarction in 97 patients
aged ≤75 years. However, in patients aged ≥75 years,
the operative death rate was 10%, and the incidence of
cerebral infarction was 8.3%. Based on these results, we
recommend TEVAR using commercially available SG
devices for high-risk patients, such as elderly patients,
as the rst choice and open surgery to relatively young
low-risk patients, considering that the long-term results
of TEVAR are still unclear. Comparison of the patients’
preoperative background between the two groups in
this study showed no signicant difference in each item
such as age. Although our policies were not always re-
ected, the reason for the selection of TEVAR widely
varied. We recommended open surgery to 9 patients in
the TEVAR group, but the patients themselves nally
selected TEVAR. This suggests marked demand for
minimal invasiveness at present. In addition, to reect
these results in future strategies, we intend to perform
closer, long-term follow up in these patients and analyze
aneurysm-associated events.
A questionnaire survey conducted in 2006 by the
Japanese Association for Thoracic Surgery showed that
arch replacement was performed by open surgery in
1544 (35.2%) of 4382 surgically treated patients with
non-ruptured thoracic aneurysms. The number of patients
who underwent this operation has been increasing. The
number of patients who underwent surgery of the de-
scending aorta was 535, also showing an annual increase.
The operative death rate was 4.5% each for aneurysms in
the aortic arch and those in the descending aorta, and the
early results of open surgery have annually improved.5)
While the surgical results have continuously improved,
medical companies and workers have made great efforts
to improve TEVAR devices, and their indications have
gradually been expanding. To expand the indications of
TEVAR to arch aneurysms, the T.M.U. type Najuta was
developed in Japan, which took the lead in developing
new devices, and favorable mid-long-term results have
gradually been reported.6) In the future, indications
for TEVAR are expected to expand further, due to an
improvement in development of devices for high-risk
patients in whom surgery was not conventionally indi-
cated, and the number of surgically treated patients with
thoracic aneurysms may also increase.
On the other hand, long-term results have not been ad-
equately claried. Makaroun et al.1) evaluated the 5 year
results of TEVAR using Gore TAG and reported that the
incidence of major adverse events related to open surgery
was 70% immediately after surgery, 77% after 1 year, and
78.7% after 2 years, but the incidence did not increase,
thereafter, until 5 years after surgery; however, that re-
lated to TEVAR using TAG was 28% immediately after
the operation, 42% after 1 year, and 57.9% after 5 years,
showing a slight increase. Therefore, in young patients
who require long-term follow-up, the risks and benets
of TEVAR should be adequately evaluated for treatment.
concluSIonS
The early-mid-term results of both TEVAR and open
surgery were favorable, but TEVAR was less invasive.
While the results of open surgery have improved, devices
for TEVAR have been developed. In high-risk patients,
the selection of less invasive TEVAR may be appropri-
ate. However, not all problems regarding the long-term
results have been overcome. According to age and the
Fig. 2 A case of TEVAR.
A: before deployment of SG.
B: after deployment of SG. The proximal landing was at Zone 1.
TEVAR: thoracic endovascular aneurysm repair; SG: stent graft
Yuri K, et al.
20 Annals of Vascular Diseases Vol.5, No.1 (2012)
general condition of the patient, open surgery may be the
rst choice. Surgical results may further improve, and
indications may further expand by selecting treatment
methods with consideration given to the advantages of
both TEVAR and open surgery.
referenceS
1) Makaroun MS, Dillavou ED, Wheatley GH, et al. Five-
year results of endovascular treatment with Gore TAG
device compared with open repair of thoracic aortic
aneurysms. J Vasc Surg 2008; 47: 912-8.
2) Bavaria JE, Appoo JJ, Makaroun MS, et al. Endo-
vascular stent grafting versus open surgical repair
of descending thoracic aortic aneurysms in low-risk
patients: a multicenter comparative trial. J Thorac
Cardiovasc Surg 2007; 133: 369-77.
3) Stone DH, Brewster DC, Kwolek CJ, et al. Stent-graft
versus open-surgical repair of the thoracic aorta: mid-
term results. J Vasc Surg 2006; 44: 1188-97.
4) Shiiya N, Matsuzaki K, Matsui Y. Stent graft vs. open
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... [18][19][20][21] in total, 15 individual studies were included in the present systematic review (figure 1). [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] The characteristics of included studies are summarized in Table i. [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] The excluded articles are summarized in supplementary digital Material 2 (supplementary Table ii). ...
... [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] The characteristics of included studies are summarized in Table i. [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] The excluded articles are summarized in supplementary digital Material 2 (supplementary Table ii). ...
... 2,6 The total inconsistency among the studies was high ( figure 4). 22,27,28,[30][31][32][33]36 The assessment indicated publication bias (P=0.044), and the quality of evidence was very low (Table ii). and osr (P=0.45). ...
Article
Introduction: Since the approval, the TEVAR is widely used for the repair of thoracic aortic aneurysm. However, the long-term mortality and re-intervention rates compared to OSR are unclear. We aimed to compare the effectiveness of the thoracic endovascular aortic repair (TEVAR) with open surgical repair (OSR) specifically for thoracic aortic aneurysms. Evidence acquisition: We conducted a comprehensive search in MEDLINE, PubMed, EMBASE, CINAHL, PROSPERO, Centre for Reviews and Dissemination, and the Cochrane Library up to November 2020. The main outcomes were early mortality, mid-to-long-term survival, and re-intervention. The quality of the evidence was assessed using the GRADE methodology. All analyses were performed using RevMan with the random effect model and Comprehensive Meta-Analysis software. Evidence synthesis: One systematic review and 15 individual studies were included. Pooled analysis showed that 30-day mortality, stroke, renal failure, and pulmonary complications were significantly lower in TEVAR vs. open surgery. The pooled rate of re-intervention significantly favored the OSR. The long-term survival and mortality favored TEVAR and OSR in one and two studies, respectively, but was non-significant in 7 analyzes. Conclusions: Early clinical outcomes including the 30-day mortality, stroke, renal failure, and pulmonary complications significantly favored the TEVAR. However, the mid-to-long-term re-intervention rate favored the OSR and long-term survival was inconsistent among the studies. The quality of evidence was very low. More studies with longer follow-ups are needed. The use of TEVAR should be decided by taking into account other factors including patient characteristics and preferences, cost, and surgeon expertise.
... In recent years, endovascular stent graft repair has been widely used in the treatment of thoracic aortic aneurysm. 5) Because endovascular stent graft repair is less invasive than open aortic repair, 6) it has become an established option in the treatment of acute aortic dissection and traumatic aortic injury. ...
Article
A 25-year-old woman committed suicide with a high-rise fall and presented hypovolemic shock caused by blunt thoracic, abdominal injury. Enhanced computed tomography scan showed the pelvic hemorrhage and the transection of the descending thoracic aorta. After urgent transcatheter arterial embolization to stabilize bleeding from pelvic fracture, the thoracic aortic injury was treated with endovascular aortic repair using a GORE TAG endograft. She recovered from her injuries, and there was no evidence of endoleak in the follow-up computed tomography scan. In the treatment of traumatic aortic injury with associated severe injuries, the management of bleeding from associated injuries is important.
... TEVAR for the descending thoracic aorta provides acceptable midterm morbidity and mortality. 1,2 For aortic arch disease, however, some challenges that relate to its angulated morphologic features and the involvement of supra-aortic branches still remain. In the mid-2000s in Japan, the precurved fenestrated endograft Najuta (Kawasumi Lab, Inc, Tokyo, Japan) was developed to achieve good conformability and to extend the proximal landing zone. ...
Article
We evaluated the results of our previous study investigating a precurved fenestrated endograft treatment for thoracic aortic aneurysms and aortic dissection extended to the aortic arch. From February 2010 to December 2011 at 35 Japanese centers, 383 patients (mean age, 75.7 ± 9.4 years) who required stent-graft landing in the aortic arch were treated with a precurved fenestrated endograft. The device has 19 3-dimensional curved stent skeleton types similar to aortic arch configurations and 8 graft fenestration types and is 24 to 44 mm in diameter and 16 to 20 cm long. The endografts were fabricated according to preoperative 3-dimensional computed tomographic images. Technical and initial successes were achieved in 380 and 364 cases, respectively. Device proximal end was at zones 0 to 2 in 363, 15, and 2 patients, respectively. Lesions' proximal end ranged from zone 0 to 3 in 16, 125, 195, and 44 patients, respectively. The mean operative and fluoroscopic times were 161 ± 76 and 26 ± 13 min, respectively. The complications included stroke (7 patients), permanent paralysis (3), and perioperative death (6). No branch occlusion or proximal migration of the device occurred during follow-up. A precurved fenestrated endograft for endovascular repair in aortic arch disease rendered catheter manipulation simple and minimized operative complication risks. Although most patients had inadequate proximal landing zone and severely angled complex configuration, low mortality and morbidity and satisfactory clinical success were early outcomes, suggesting that this simplified treatment may be effective for aortic arch disease.
Article
Objective: A systematic review and meta-analysis was conducted to evaluate the effectiveness of thoracic endovascular aortic repair (TEVAR) and open repair in patients with descending thoracic aortic aneurysms (TAAs). Methods: PubMed, Ovid MEDLINE, Ovid Embase, EBSCO Cumulative Index to Nursing and Allied Health Literature, and Scopus were searched from each database's inception to January 29, 2016. We selected studies that compared the two approaches in adults with TAAs and reported 30-day mortality or procedure complications. Two reviewers independently extracted data, and conflicts were resolved by consensus. Random-effects meta-analysis was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). The main outcomes and measures were all-cause 30-day mortality, 30-day paraplegia or spinal cord ischemia, stroke, pulmonary complications, and length of hospital and intensive care unit (ICU) stay. Results: Twenty-seven studies of moderate methodologic quality were included. TEVAR was associated with lower 30-day mortality in ruptured (OR, 0.58; 95% CI, 0.38-0.88) and intact (OR, 0.6; 95% CI, 0.36-0.99) aneurysms. Paraplegia or spinal cord ischemia (OR, 0.35; 95% CI, 0.2-0.61) and pulmonary complications (OR, 0.41; 95% CI, 0.37-0.46) were reduced in patients undergoing TEVAR, whereas a reduction in stroke risk was not statistically significant (OR, 0.89; 95% CI, 0.76-1.03). Pooled mean difference in length of hospital and ICU stay was lower for TEVAR by -5.17 days (95% CI, -7.77 to -2.57) and -5.89 days (95% CI, -9.65 to -2.12), respectively. Three studies showed that compared with open repair, a hybrid approach reduced hospital stay (pooled mean difference, -8.83 days; 95% CI, -14.37 to -3.29) and ICU stay (pooled mean difference, -3.17 days (95% CI, -5.54 to -0.97), with minimal evidence on other outcomes studied. Conclusions: Observational evidence at high risk of confounding suggests that compared with open repair for TAA, TEVAR reduced risk of mortality, paraplegia, spinal cord ischemia, and pulmonary complications within 30 days of intervention. Patients undergoing TEVAR also had shorter length of hospital and ICU stay compared with patients undergoing open repair.
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Aortic arch aneurysms are extremely burdensome to treat due to their surgical complexity. In particular, postoperative brain disorders are severe complications that significantly lower patient quality of life (QOL). Surgical treatment has recently changed to minimally invasive procedures to respect patient needs and improve postoperative QOL. As pioneers in arch aneurysm surgery, we have achieved solid results with the open stent grafting technique since 1994 and debranched thoracic endovascular aortic repair since 1997. We also developed a new method of implanting a branched open stent (BOS) graft in the entire distal anastomotic portion, which does not require suturing or lateral thoracotomy. Recently, a clinical trial of the Najuta fenestrated endograft device have been started. Here, we report early and long-term results involving hybrid endovascular repair of aortic arch aneurysms. Our findings suggest that while fenestrated and branched grafts hold promise for treating aortic arch conditions, hybrid endovascular repair may become the first choice for treating aortic aneurysms.
Article
In the West, stent grafts for endovascular repair of thoracic aortic aneurysms have been commercially available for several years, whereas in Japan, a manufactured stent graft was not approved for this application until March 2008. Nevertheless, endovascular thoracic intervention began to be performed in Japan in the early 1990s, with homemade devices used in most cases. Many researchers have continued to develop homemade devices. We have participated in joint design and assessment efforts with a stent graft manufacturer, focusing primarily on fenestrated stent grafts used in repairs at the distal arch, a site especially prone to aneurysm. From 1995 to February 2008, we performed about 1100 endovascular procedures to treat thoracic aortic aneurysms and 682 cases were performed at Tokyo Medical University. In 435 out of 682 the aneurysm was located in the area from the distal arch to the proximal descending aorta. Fenestrated stent grafts were inserted in 288 cases. Computed tomography scans were performed at 3, 6, and 12 months postoperatively and annually thereafter. The initial success rate in the entire series was 95.2%. Complications included 26 cerebral infarctions (3.8%), six of which (0.9%) resulted in serious paralysis and changes in consciousness. Among patients who received fenestrated stent grafts, paraplegia occurred in 2.6%, aortic injury in 1.2%, and iliofemoral artery injury in 6.0%. No complications resulted from occlusion of aortic arch branches. At >/=2 years after intervention, aneurysm diameter was reduced in 62% of patients, 33% had no change, and 5% had a diameter enlargement. The stent graft complication rate during follow-up was 8.4%, the device fracture rate was 1.4%, and the device migration rate was 7%. The 5-year survival rate was 62.4%, with follow-up in 96.8% of the patients. Endovascular repair has promising results in the descending thoracic aortic region, although some stent grafts and their delivery systems can still be improved. Additional commercial developments and available stent grafts designed for use in the distal arch are urgently needed.
Article
Pivotal and comparative trial data are emerging for stent graft (SG) vs open repair of the thoracic aorta. We reviewed procedure-related perioperative morbidity, mortality, and mid-term outcomes in a contemporary series of patients treated with SG of the thoracic aorta. The data were compared with those of a patient cohort concurrently treated with open surgical repair confined to the descending aorta. A review of patients undergoing SG procedures and open surgery of the thoracic aorta from January 1, 1996, to November 30, 2005, was performed from a prospectively compiled database. Study end points included perioperative complications, late survival, freedom from reinterventions, and graft-related complications. Multivariate methods were used to assess variables potentially associated with study end points; late outcomes were compared with actuarial methods. In 105 patients (mean age, 70 years; 66 male [62.9%]) SG repairs were done for 68 degenerative aneurysms (64.7%), 12 penetrating ulcers (11.4%), 15 pseudoaneurysms (14.3%), 9 traumatic tears (8.6%), and 1 acute dissection (0.9%). Mean follow-up was 22 months (range, 0 to 101 months). Eighty-nine (84.8%) SG patients were asymptomatic at presentation and underwent elective repair, whereas 16 (15.2%) presented with acute conditions and underwent urgent repair. Perioperative mortality was 7.6% (8/105), and actuarial survival at 48 months was 54% +/- 7%. The perioperative mortality rate among SG patients treated for degenerative pathology was 10.4% (8/77). Seven (6.7%) of 105 patients experienced spinal cord ischemic complications, including 2 patients with transient paraparesis that resolved by the time of discharge. Reinterventions were performed in 10.5% of patients (11/105), with freedom from reintervention approaching 81% by 48 months. Over the same interval, 93 patients were treated with open-surgical repair for descending thoracic aneurysm (anastomosis cephalad to the celiac axis). Perioperative mortality in the open cohort was 15.1% (14/93; P = .09 vs SG repair), and the 48-month actuarial survival was 64% +/- 6%. The incidence of spinal cord ischemic complications was 8.6% (8/93), including 4 patients with transient paraparesis (P = .44 vs SG repair). Nine patients (9.7%) required surgical reintervention during the follow-up period, with 48-month freedom from reintervention approaching 79% (P = .73 vs SG repair). Operative mortality was halved with SG, with similar late survival for both cohorts. Reinterventions were required at a nearly identical rate for open repair and SG, and both groups experienced similar rates of spinal cord ischemic complications.
Article
Results are presented from the first completed multicenter trial directed at gaining approval from the US Food and Drug Administration of endovascular versus open surgical repair of descending thoracic aortic aneurysms. Between September 1999 and May 2001, 140 patients with descending thoracic aneurysms were enrolled at 17 sites and evaluated for a Gore TAG Thoracic Endograft. An open surgical control cohort of 94 patients was identified by enrolling historical and concurrent subjects. Patients were assessed before treatment, at treatment, and at hospital discharge and returned for follow-up visits at 1 month, 6 months, and annually thereafter. One hundred thirty-seven of 140 patients had successful implantation of the endograft. Perioperative mortality in the endograft versus open surgical control cohort was 2.1% (n = 3) versus 11.7% (n = 11, P < .001). Thirty-day analysis revealed a statistically significant lower incidence of the following complications in the endovascular cohort versus the surgical cohort: spinal cord ischemia (3% vs 14%), respiratory failure (4% vs 20%), and renal insufficiency (1% vs 13%). The endovascular group had a higher incidence of peripheral vascular complications (14% vs 4%). The mean lengths of intensive care unit stay (2.6 +/- 14.6 vs 5.2 +/- 7.2 days) and hospital stay (7.4 +/- 17.7 vs 14.4 +/- 12.8 days) were significantly shorter in the endovascular cohort. At 1 and 2 years' follow-up, the incidence of endoleaks was 6% and 9%, respectively. Through 2 years of follow-up, there were 3 reinterventions in the endograft cohort and none in the open surgical control cohort. Kaplan-Meier analysis revealed no difference in overall mortality at 2 years. In this multicenter study early outcomes with descending aortic endovascular stent grafting were very encouraging when compared with those of a well-matched surgical cohort. However, at 2 years' follow-up, there is an incidence of endoleaks and reinterventions associated with endovascular versus open surgical repair. Continued vigilant surveillance of patients treated with an endograft is important.
Article
Report the results of a phase II multicenter, prospective trial comparing endovascular treatment of descending thoracic aneurysm (TEVAR) with the TAG device to surgical controls after 5 years of follow-up. The Gore TAG trial compared the TAG endograft patients (n = 140) with standard open surgical controls (n = 94) with enrollment from September of 1999 to May of 2001. An additional 51 patients were enrolled in 2003 after revision of the endograft. Follow-up consisted of patient visits, computed tomography (CT) scans and x-rays at 1, 6, and 12 months and yearly. Significant sac size change was defined as >or=5 mm increase or decrease from the 1 month baseline measurement. Migration was defined as >or=10 mm cranial or caudal movement of the device inside the aorta. Significance was determined as P <or= .05. At 5 years, aneurysm-related mortality was lower for TAG patients at 2.8% compared with open controls at 11.7% (P = .008). No differences in all-cause mortality were noted, with 68% of TAG patients and 67% of open controls surviving to 5 years (P = .43). Major adverse events at 5 years were significantly reduced in the TAG group; 57.9% vs 78.7% (P = .001). Endoleaks in the TAG group decreased from 8.1% at 1 month to 4.3% at 5 years. Five TAG patients have undergone major aneurysm-related re-interventions at 5 years (3.6%), including one arch aneurysm repair for type 1 endoleak and migration, one open conversion and five endovascular procedures for endoleaks in three patients. There were fewer secondary procedures not directly related to aneurysm repair in the TAG vs the open repair group at 5 years, 15.0% vs 31.9%, (P = .01). For TAG patients, sac size at 60 months decreased in 50% and increased in 19% compared with the 1-month baseline. Comparison with the modified low-porosity device at 24 months showed sac increase in 12.9% of original vs 2.9% in modified grafts (P = .11). At 5 years, there have been no ruptures, one migration, no collapse, and 20 instances of fracture in 19 patients, all before the revision of the TAG graft. In anatomically suitable patients, TAG treatment of thoracic aneurysms is superior to surgical repair at 5 years. Although sac enlargement is concerning, early modified device results indicate this issue may be resolved.
Stent graft vs. open surgery in the descending thoracic aorta: Patients' characteristics and mid-term results with the homemade device
  • N Shiiya
  • K Matsuzaki
  • Y Matsui
Shiiya N, Matsuzaki K, Matsui Y. Stent graft vs. open surgery in the descending thoracic aorta: Patients' characteristics and mid-term results with the homemade device. J Jpn Coll Angiol 2009; 49: 281-6. (in Japanese)