Endovascular aneurysm repair: prevention and treatment of complications
Goudeketting, Seline
DOI:
10.33612/diss.98524202
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Goudeketting, S. (2019). Endovascular aneurysm repair: prevention and treatment of complications.
Rijksuniversiteit Groningen. https://doi.org/10.33612/diss.98524202
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Systematic Review and
Meta-Analysis of Elective and
Urgent Late Open Conversion
after Failed Endovascular
Aneurysm Repair
J Vasc Surg. 2019 Aug;70(2):615-628
Seline R. Goudeketting
P. H. Ping Fung Kon Jin
Çağdaş Ünlü
Jean-Paul P.M. de Vries
ABSTRACT
Background: In this study, we systematically reviewed late open conversions after
failed endovascular aneurysm repair (EVAR), assessed the methodologic quality of the
included studies, and performed a meta-analysis on the 30-day mortality rates for
urgent and elective late conversions.
Methods: Electronic databases were systematically searched for studies published
up to June 2018 that focused on late open conversion of failed EVAR (i.e., >30 days
after the initial EVAR), reported the primary outcome of 30-day mortality rate, and
distinguished the 30-day mortality rate between urgent and elective late conversions.
Two independent reviewers assessed the methodologic quality of the included studies
with the Methodological Index for Non-Randomized Studies (MINORS). Data on
baseline demographics, indication for conversion, surgical approach, and early and
late mortality rates were recorded. Reported data correspond to the average or range
of the means reported in the individual studies. A random-effects model was used to
pool 30-day mortality rates for urgent and elective late conversion.
Results: There were 27 retrospective studies with a total of 791 patients available for
analysis, with 617 elective and 174 urgent late conversions. The methodologic quality
was mostly poor (median, 6; interquartile range, 5-7). The mean time from primary
EVAR to conversion was 35.1 months (95% confidence interval [CI], 30.4-39.8 months).
The most commonly explanted endografts were Excluder (W. L. Gore & Associates,
Flagstaff, Ariz) in 16.2%, Talent (Medtronic, Minneapolis, Minn) in 14.5%, and AneuRx
(Medtronic) in 13.7%. Nineteen other types of endografts were used in 43.3%; the type
of endograft was not reported in 12.3%. A transperitoneal approach was used in a mean
74.0% of conversions (95% CI, 70.9%-77.0%), and complete endograft explantation was
performed in 478 (60.4%) patients (95% CI, 57.0%-63.8%). The complication rate was
36.7% (95% CI, 27.0%-46.4%). Temporary or permanent hemodialysis after conversion
was required in 3.9% of patients (95% CI, 2.6%-5.2%). The pooled estimate for the
30-day mortality rate was 2.8% (95% CI, 1.5%-4.0%; P < .726) for elective late conversions
and 28.1% (95% CI, 18.9%-37.3%; P < .001) for urgent late conversions.
Conclusions: Type I endoleak and rupture are the most common indications for,
respectively, elective and urgent conversions. A 10 times higher 30-day mortality rate
was observed for patients treated with late open conversion in an urgent vs elective
setting. The 30-day mortality rate of elective late open conversions is almost comparable
to that of primary elective open abdominal aortic aneurysm repair procedures. For the
9
interpretation of the outcomes of the review, however, the methodologic quality of
the available literature should be considered.
INTRODUCTION
Endovascular aneurysm repair (EVAR) is widely performed in the treatment of
abdominal aortic aneurysms (AAAs). Follow-up imaging is regularly performed after
EVAR to assess for late complications. Commonly observed complications that
can arise are endoleaks, migration, and infection, which may increase the pressure
on the aneurysm sac and, if left untreated, increase the risk for aneurysm rupture.
1Endovascular reinterventions to solve these complications are often performed and
include deployment of proximal or distal extensions or both, device relining, use of the
Heli-FX EndoAnchor system (Medtronic Vascular, Santa Rosa, Calif), and embolization
of endoleaks.
2–4The rationale behind these endovascular salvage procedures is that there is a
considerable risk associated with open conversion after failed EVAR
2,3; mortality rates
of elective open conversion and primary open surgical repairs have been reported
to be 3.3% to 10.0% and 0.9% to 4.2%, respectively.
5-11Explantation of an endograft
may be technically challenging and can increase perioperative mortality and morbidity
rates.
12,13The overall incidence of late open surgical conversion has been reported
to be between 0.4% and 22%.
3,14-17Reports on conversion are often focused on older
generation endografts that are no longer available.
17However, with an increase in the
number of patients treated by EVAR, the number of patients without possibility for
further endovascular salvage procedures is likely to increase, which may lead to an
increase in late explantations despite newer generation endografts.
17-19Kouvelos et al.
20reviewed studies of late endograft conversion after EVAR up
to 2014. Although the review was elaborate, the difference between an urgent and
elective setting could not be obtained from the included data.
21-23Furthermore, many
small studies (<10 patients) were included, which influences the robustness of the data.
This analysis includes 10 new recently published studies of late open conversions.
The aim of this study was to systematically review all available data on late open EVAR
conversions, to assess the methodologic quality of the included studies, and to perform
a meta-analysis on the 30-day mortality rate for elective and urgent late conversions.
METHODS
Literature search
Eligible articles were sought through a literature search in electronic databases:
PubMed/MEDLINE, Embase, and the Cochrane Database of Controlled Trials. The
search included the following keywords (limited to the title and abstract): (endovascular
9
OR endoprosthe* OR stentgraft* OR (stent graft*) OR endograft* OR EVAR OR EVAS
OR seal* OR Nellix OR (sac anchor*) OR (aneurysm seal*)) AND ((aortic aneurysm,
abdominal [MESH]) OR (aneurysm* AND aort* AND abdom*) OR AAA) AND (explant*
OR excision* OR conver* OR redo* OR revis* OR rescue*). Combinations of these
keywords were added to the search. The latest search was performed in June 2018.
The search was limited to articles published in English (independent of the country of
publication). No time restraint was used. RefWorks software (RefWorks, Bethesda, Md)
was used to remove duplicates retrieved from the three electronic databases.
Inclusion and exclusion criteria and data collection
Articles were identified that met the following criteria: late open conversions (i.e.,
endograft explantation >30 days after the initial implantation procedure) of EVAR
and endovascular aneurysm sealing; 30-day mortality rate as the primary outcome;
and possibility to distinguish the 30-day mortality rate between urgent and elective
conversions. Urgent conversions comprised conversions performed for symptomatic
aneurysms, ruptured aneurysms, stent graft infections, aortoduodenal fistulas, and
stent graft thromboses. In case of duplicate data, the most recent article was included.
Articles were excluded when they were case reports or series with <10 patients,
technical descriptions of the conversion, reviews, or letters to the editor.
Titles and abstracts of articles were reviewed and selected independently by two
reviewers (S.R.G. and P.H.P.F.K.J.). The full article was evaluated if one or both of the
reviewers found the article eligible. A cross-check was performed to identify relevant
articles from the reference lists of the eligible articles. The relevant articles were added
to the included studies, and the full-text was assessed.
Extracted data of the articles included the year of publication, study design, and
study time frame. The following variables were also obtained for urgent and elective
conversion: number of patients, baseline demographics (definitions were provided in
the studies and included hypertension, coronary artery disease, smoking, and diabetes
mellitus), indication for endograft explantation, time to conversion, AAA diameter at
the time of conversion, type of endograft, complete or partial explantation, surgical
method, 30-day mortality rate, complication rate, and mortality rate during follow-up.
Quality assessment
The Methodological Index for Non-Randomized Studies (MINORS)
24consists of 12
items and was used to assess the methodologic quality of the studies. Each item is
rated 0 to 2 (0, not reported; 1, reported but inadequate; or 2, reported and adequate).
The index system for noncomparative studies consists of 8 items, whereas comparative
studies have 12 items to be scored. A total of 16 points (noncomparative studies) or 24
points (comparative studies) can be achieved. For comparative studies, scores ≤14, 15
to 22, and ≥23 were considered poor, moderate, and good quality, respectively. The
noncomparative studies were considered poor, moderate, and good when the score
ranked ≤8, 9 to 14, and 15 or 16. Two reviewers (S.R.G. and P.H.P.F.K.J.) independently
scored the articles. In case of discrepancy, the opinion of a third reviewer (J.P.P.M.V.)
was sought until consensus was reached.
Outcome measures and data analysis
The primary outcome measure was the 30-day mortality rate. Normality of the data
was assessed with the Shapiro-Wilk test using SPSS Statistics 24.0 software (IBM,
Armonk, NY). Normally and non-normally distributed data are reported as mean with
95% confidence interval (CI) or median and interquartile range (IQR), respectively, and
correspond to the average or range of the means reported in the individual studies.
The 95% CI was used to estimate proportions of the population. The difference
between the primary outcomes of both groups was calculated with an independent
samples t-test. Pooled data analysis was performed with a random-effects model. The
presence of heterogeneity was examined with Χ
2heterogeneity tests, I
2indexes, and
forest plots. The meta-analysis was performed with Meta-Analyst 3.1 software (Tufts
University, Medford, Mass).
RESULTS
Included studies
The search resulted in 2069 records, of which 1516 were duplicates or irrelevant to the
topic. After detailed evaluation of the titles and abstracts, the full text was assessed for
57 articles (Figure 9.1). The cross-check identified three additional eligible studies.
18,25,26After exclusion of articles with <10 patients and reports of duplicate or mixed data
(Appendix I), 27 articles met the inclusion criteria.
13,18,19,25-48All 27 studies were retrospective. A total of 791 patients underwent a late
conversion, 617 elective and 174 urgent. The overall reported center incidence of late
conversions of 21 studies was 5.3% (95% CI, 3.1%-7.4%). Four studies did not
31,32,34or
vaguely reported
13on the total number of EVAR procedures performed during the
study period, one study
33reported on the total number of EVAR procedures for eight
centers (and the incidence per center was not clarified), and one study reported
the number enrolled in the study
30instead of the incidence of conversions. The
patients were a mean age of 73.5 years (95% CI, 72.3-74.7 years), and 79% were men.
Hypertension was reported in 50.7% of patients (95% CI, 47.2%- 54.2%), coronary artery
9
disease in 39.6% (95% CI, 36.2%-43.0%), smoking in 25.5% (95% CI, 22.5%-28.6%),
and diabetes mellitus in 12.3% (95% CI, 10.0%-14.5%). Hypertension, coronary artery
disease, smoking and diabetes mellitus was not reported in, respectively, 302 (38.2%),
186 (23.5%), 335 (42.4%), and 302 patients (38.2%). Other characteristics and outcomes
of the included studies are reported in Table 9.1.
The time frame of reviewed cases ranged from 1992 to 2016, with a maximum
time span of 21 years. Figure 9.2 shows the number of late conversions performed in
an urgent and elective setting, the mortality rate per setting, and the corresponding
time frames. The mean time from primary EVAR implantation to conversion was 35.1
months (95% CI, 30.4-39.8 months; range, 1-228 months) but it was not reported in 41
patients of two studies.
36,48The MINORS scores are reported in Table 9.2. The median MINORS score was
6 (IQR, 5-7). Most studies were of poor methodologic quality, mostly because of
the retrospective nature of the studies; that is, prospective collection of data and
prospective calculation of the study size were not applicable. Three noncomparative
studies
34,42,48were of moderate quality, and in only one study
37was elective open
surgical conversion for type IA endoleak compared with elective primary open
juxtarenal aneurysm repair.
Search results (n = 2069) 1091 Pubmed/Medline 925 Embase
53 Cochrane database of controlled trials
Removed studies (n = 496) No conversion of failed EVAR No 30-day mortality as endpoint Reviews of conversion after EVAR Detailed evaluation of title/abstracts by
both reviewers (n = 553)
Removed studies (n = 1516) Duplicate publications Irrelevant to the topic
Letters to the editor/Congress abstracts
Removed studies (n = 3) Solely early conversions: 3 Excluded studies (n = 30) N <10 (n = 14)
Duplicate data (n = 5) Mixed data (n = 11) Full text assessed (n = 57)
Included articles (n = 27) Additional studies from reference
list of full text (n = 3)
Figure 9.1. Flow chart of literature search strategy. EVAR, endovascular aneurysm repair.
Table 9.1. Studies included in the analysis.
Study Study type La
te
conversions per total EV
AR
performed Total la
te
conversions, N E/U N Age, years Male sex Surgical approach Clamp loca
tion
Time implant to conversion, mo AAA size a
t
conversion, mm Partial explant 30-day mortality ra
te Overall mortality ra te MINORS Arya, 201344 R+SC 270 (14.4) 39 E 30 73a 14 (51.8) RP: 5, TP: 34 Supraceliac: 7 Suprarenal: 12, Infrarenal: 20, 41.7 (2.2-118.4)b 71±36a 19 (70.4) 0 (0.0) 8 (20.5) 5 U 9 69.7a 11 (91.7) 62±41a 1 (8) 2 (22.2) Ben Abdallah, 201745 R+SC 338 (9.2) 31 E 19 73±11 15 (79) TP: 19 Supraceliac: 1, Suprarenal: 7, Interrenal: 3, Infrarenal: 20 36 (0-97)c 58±10 17 (55) 0 (0.0) 3 (9.7) 8 U 12 72±11 11 (92) TP: 12 35 (2-228)c 59±10 2 (16.7) Böckler, 200246 R+SC 520 (3.8) 20 E 17 NR NR NR IN 12 (0.8-50)c NR NR 0 (0.0) 3 (15.0) 4 U 3 3 (100) Bonardelli, 201843 R+SC 435 (5.5) 24 E 21 75 (48-79)b 23 (95%) TP: 21 Suprarenal: 14 Infrarenal: 10 49 (27-70) IN 5 (21) 0 (0.0) 2 (8.3) 7 U 3 TP: 3 0 (0.0) Brewster, 200626 R+SC 873 (1.7) 15 E 10 NR NR NR NR 31 (6-96)b NR NR 1 (10) 3 (20.0) 6 U 5 2 (40) Brinster, 201147 R+SC 1273 (1.6) 21 E 16 75 (59-88)b 16 (76) RP: 17 TP: 4 Supraceliac: 9, Suprarenal:7, Infrarenal: 5 33.4 (2-73)b NR 4 (19.0) 0 (0.0) 0 (0.0) 6 U 5 0 (0.0) Chaar, 201219 R+two centres Total: 1682 (2.6) Center1: 1549 (2.6) Center2: 133 (3.0) 44 E 19 75a 16 (84) RP: 1 TP: 43 Supraceliac: 2, Suprarenal: 9, Infrarenal: 3, No clamping: 5 45 (2-190)b 62±16 7 (36.8) 1 (5.3) 16 (36.4) 7 U 25 73a 18 (72) Supraceliac: 7, Suprarenal: 11, Infrarenal: 4, No clamping: 3 3 (12) 7 (28) Ferrero, 201348 R+SC 415 (4.8) 20 E 13 75.4±6.7 19 (95) TP: 11 BS: 2 Suprarenal: 1, Unclear: 12 64.2±35.7 70±15 4 (20) 0 (0.0) 4 (20.0) 9 U 7 TP: 6 BS: 1 Suprarenal: 1, Unclear: 6 NR 4 (57.1) Jacobowitz, 199927 R+MC 669 (3.6) 24 E 20 70.2±7.7 23 (96) IN IN 17 (1-40)b NR 0 (0) 0 (0.0) 1 (4.2) 3 U 4 22 (4-31)c 1 (25) Joo, 201842 R+SC 566 (5.3) 30 E 24 67.9 (48-83)b 25 (83.3) RP: 3 TP: 27 Supraceliac: 10 Suprarenal: 2 Infrarenal: 17 Endoballoon: 1 48.6 (2-190)b 65.3±17.4 13 (43.4) 1 (4.1) 5 (16.7) 10 U 6 2 (33.3) Kansal, 201828 R+SC 1060 (1.5) 16 E 10 79 (76-81.7) 12 (75) RP: 3, TP: 13 Supraceliac: 5, Supramesenteric: 1, Suprarenal: 2, Infrarenal: 3, No clamping: 5 43.4 (25.7-64.8) 56 (54-71) 3 (30) 1 (10) 4 (25.0) 7 U 6 21.1 (3.8-54) 2 (33.3) 2 (33.3)
9
Table 9.1. Studies included in the analysis.
Study Study type La
te
conversions per total EV
AR
performed Total la
te
conversions, N E/U N Age, years Male sex Surgical approach Clamp loca
tion
Time implant to conversion, mo AAA size a
t
conversion, mm Partial explant 30-day mortality ra
te Overall mortality ra te MINORS Arya, 201344 R+SC 270 (14.4) 39 E 30 73a 14 (51.8) RP: 5, TP: 34 Supraceliac: 7 Suprarenal: 12, Infrarenal: 20, 41.7 (2.2-118.4)b 71±36a 19 (70.4) 0 (0.0) 8 (20.5) 5 U 9 69.7a 11 (91.7) 62±41a 1 (8) 2 (22.2) Ben Abdallah, 201745 R+SC 338 (9.2) 31 E 19 73±11 15 (79) TP: 19 Supraceliac: 1, Suprarenal: 7, Interrenal: 3, Infrarenal: 20 36 (0-97)c 58±10 17 (55) 0 (0.0) 3 (9.7) 8 U 12 72±11 11 (92) TP: 12 35 (2-228)c 59±10 2 (16.7) Böckler, 200246 R+SC 520 (3.8) 20 E 17 NR NR NR IN 12 (0.8-50)c NR NR 0 (0.0) 3 (15.0) 4 U 3 3 (100) Bonardelli, 201843 R+SC 435 (5.5) 24 E 21 75 (48-79)b 23 (95%) TP: 21 Suprarenal: 14 Infrarenal: 10 49 (27-70) IN 5 (21) 0 (0.0) 2 (8.3) 7 U 3 TP: 3 0 (0.0) Brewster, 200626 R+SC 873 (1.7) 15 E 10 NR NR NR NR 31 (6-96)b NR NR 1 (10) 3 (20.0) 6 U 5 2 (40) Brinster, 201147 R+SC 1273 (1.6) 21 E 16 75 (59-88)b 16 (76) RP: 17 TP: 4 Supraceliac: 9, Suprarenal:7, Infrarenal: 5 33.4 (2-73)b NR 4 (19.0) 0 (0.0) 0 (0.0) 6 U 5 0 (0.0) Chaar, 201219 R+two centres Total: 1682 (2.6) Center1: 1549 (2.6) Center2: 133 (3.0) 44 E 19 75a 16 (84) RP: 1 TP: 43 Supraceliac: 2, Suprarenal: 9, Infrarenal: 3, No clamping: 5 45 (2-190)b 62±16 7 (36.8) 1 (5.3) 16 (36.4) 7 U 25 73a 18 (72) Supraceliac: 7, Suprarenal: 11, Infrarenal: 4, No clamping: 3 3 (12) 7 (28) Ferrero, 201348 R+SC 415 (4.8) 20 E 13 75.4±6.7 19 (95) TP: 11 BS: 2 Suprarenal: 1, Unclear: 12 64.2±35.7 70±15 4 (20) 0 (0.0) 4 (20.0) 9 U 7 TP: 6 BS: 1 Suprarenal: 1, Unclear: 6 NR 4 (57.1) Jacobowitz, 199927 R+MC 669 (3.6) 24 E 20 70.2±7.7 23 (96) IN IN 17 (1-40)b NR 0 (0) 0 (0.0) 1 (4.2) 3 U 4 22 (4-31)c 1 (25) Joo, 201842 R+SC 566 (5.3) 30 E 24 67.9 (48-83)b 25 (83.3) RP: 3 TP: 27 Supraceliac: 10 Suprarenal: 2 Infrarenal: 17 Endoballoon: 1 48.6 (2-190)b 65.3±17.4 13 (43.4) 1 (4.1) 5 (16.7) 10 U 6 2 (33.3) Kansal, 201828 R+SC 1060 (1.5) 16 E 10 79 (76-81.7) 12 (75) RP: 3, TP: 13 Supraceliac: 5, Supramesenteric: 1, Suprarenal: 2, Infrarenal: 3, No clamping: 5 43.4 (25.7-64.8) 56 (54-71) 3 (30) 1 (10) 4 (25.0) 7 U 6 21.1 (3.8-54) 2 (33.3) 2 (33.3)
9
Table 9.1. continued
Study Study type La
te
conversions per total EV
AR
performed Total la
te
conversions, N E/U N Age, years Male sex Surgical approach Clamp loca
tion
Time implant to conversion, mo AAA size a
t
conversion, mm Partial explant 30-day mortality ra
te Overall mortality ra te MINORS Klonaris, 201429 R+SC 442 (4.1) 18 E 15 73.9 (55-91)b 17 (94.4) RP: 1 TP: 16 T: 1 Suprarenal: 2 Infrarenal: 10, No clamping: 6, 36 (2-120)b 73 (61-120)b 6 (33.3) 0 (0.0) 1 (6.3) 7 U 3 1 (33.3) Kong, 200530 R+MC 594 (2.7)d 16 E 15 75 (62-83)b 13 (81) NR NR 34±17 68±14 NR 0 (0.0) 2 (12.5) 5 U 1 1 (100) Lipsitz 200325 R+SC 386 (2.8) 11 E 5 76±8.4 11 (100) RP: 1, TP: 9, TL: 1 Supraceliac: 1, Suprarenal: 1, Infrarenal: 2, Graft: 1 30 (10-64)b 84 (60-120)b 8 (72.7) 1 (20) 2 (18.2) 7 U 6 Supraceliac: 2, Infrarenal: 4 1 (16.7) Marone, 201331 R+SC NR 54 E 47 73±5.6 47 (87) TP: 47 Supraceliac: 14, Suprarenal: 15, Infrarenal: 25 63 (3-102)b 58 (45-83)b 37 (68.5) 0 (0.0) 11 (20.3) 7 U 7 TP: 7 1 (14.3) Menna, 201532 R+SC NR 26 E 24 74.7±8.3 24 (92.3) TP: 20, T: 6 Supraceliac: 6, Suprarenal: 14, Infrarenal: 6 40.4±29.2 NR 2 (7.7) 6 (25) 10 (38.5) 6 U 2 0 (0.0) Millon, 200933 R+MC 1588 (1.3)e 20 E 12 73 (57-84)b IN RP: 3 TP: 17 Supraceliac: 2, Suprarenal: 6, Interrenal: 2, Infrarenal: 10 41 (2-117)b 59.1 (45-110)b 3 (15) 1 (8.3) 8 (40.0) 6 U 8 2 (25) Nabi, 200913 R+SC >600 12 E 12 81±6.2 9 (75) RP: 4 TP: 8 Infrarenal: 6, No clamping: 6 44.7 (7-80)b 79±13 6 (50) 1 (8.3) 1 (8.3) 6 Perini, 201734 R+SC NR 28 E 21 75.1±6.7 26 (92.9) TP: 21 Infrarenal: 21 41.4 (6.0-112.7)c NR 20 (71.4) 2 (9.5) 9 (32.1) 10 U 7 TP: 7 Infrarenal: 7 0 (0.0) Phade, 201135 R+SC 531 (3.0) 16 E 15 73 (41-84)b 15 (94) RP: 3 TP: 13 Supraceliac: 12, Suprarenal: 3, Infrarenal:1 29a NR NR 1 (6.7) 4 (25.0) 4 U 1 1 (100) Pitoulias, 200936 R+SC 625 (6.2) 39 E 34 70.2±6.3 32 (82.1) TP: 34 Infrarenal: 36, NR: 3 NR 57.1±8.1 3 (7.7) 3 (8.8) 4 (10.3) 5 U 5 TP: 5 39±5.1 1 (20) Scali, 201437 Case-control R+SC 873 (6.2) 25 E 25 72.8±10.0 20 (80) RP: 14 TP: 11 Supramesenteric: 9, Suprarenal: 11, Infrarenal: 5 27 (10-63) 72±17 4 (16) 1 (4) 4 (16.0) 14 Tiesen-hausen, 200638 R+SC 114 (22.8) 26 E 20 67.6 (50.6-79.7)b 17 (85) RP: 3 TP: 16 TL: 1 Supraceliac: 1, Suprarenal: 1, Infrarenal: 18 42.1 (0.03-80.4)b NR 13 (50) 0 (0.0) 3 (11.5) 4 U 6 71.7 (62.9-77.6)b 5 (83.3) TP: 6 Infrarenal: 6 31.3 (0.03-61.5)b 3 (50) Turney, 201418 R+SC 1881 (5.3) 100 E 71 75 (50-93)b 91 (91) RP: 56 TP: 44 Supraceliac: 54, Suprarenal: 33, Infrarenal: 13 41 (1-144)c NR 22 (22) 7 (9.9) 17 (17.0) 4 U 29 10 (34.5)
9
Table 9.1. continued
Study Study type La
te
conversions per total EV
AR
performed Total la
te
conversions, N E/U N Age, years Male sex Surgical approach Clamp loca
tion
Time implant to conversion, mo AAA size a
t
conversion, mm Partial explant 30-day mortality ra
te Overall mortality ra te MINORS Klonaris, 201429 R+SC 442 (4.1) 18 E 15 73.9 (55-91)b 17 (94.4) RP: 1 TP: 16 T: 1 Suprarenal: 2 Infrarenal: 10, No clamping: 6, 36 (2-120)b 73 (61-120)b 6 (33.3) 0 (0.0) 1 (6.3) 7 U 3 1 (33.3) Kong, 200530 R+MC 594 (2.7)d 16 E 15 75 (62-83)b 13 (81) NR NR 34±17 68±14 NR 0 (0.0) 2 (12.5) 5 U 1 1 (100) Lipsitz 200325 R+SC 386 (2.8) 11 E 5 76±8.4 11 (100) RP: 1, TP: 9, TL: 1 Supraceliac: 1, Suprarenal: 1, Infrarenal: 2, Graft: 1 30 (10-64)b 84 (60-120)b 8 (72.7) 1 (20) 2 (18.2) 7 U 6 Supraceliac: 2, Infrarenal: 4 1 (16.7) Marone, 201331 R+SC NR 54 E 47 73±5.6 47 (87) TP: 47 Supraceliac: 14, Suprarenal: 15, Infrarenal: 25 63 (3-102)b 58 (45-83)b 37 (68.5) 0 (0.0) 11 (20.3) 7 U 7 TP: 7 1 (14.3) Menna, 201532 R+SC NR 26 E 24 74.7±8.3 24 (92.3) TP: 20, T: 6 Supraceliac: 6, Suprarenal: 14, Infrarenal: 6 40.4±29.2 NR 2 (7.7) 6 (25) 10 (38.5) 6 U 2 0 (0.0) Millon, 200933 R+MC 1588 (1.3)e 20 E 12 73 (57-84)b IN RP: 3 TP: 17 Supraceliac: 2, Suprarenal: 6, Interrenal: 2, Infrarenal: 10 41 (2-117)b 59.1 (45-110)b 3 (15) 1 (8.3) 8 (40.0) 6 U 8 2 (25) Nabi, 200913 R+SC >600 12 E 12 81±6.2 9 (75) RP: 4 TP: 8 Infrarenal: 6, No clamping: 6 44.7 (7-80)b 79±13 6 (50) 1 (8.3) 1 (8.3) 6 Perini, 201734 R+SC NR 28 E 21 75.1±6.7 26 (92.9) TP: 21 Infrarenal: 21 41.4 (6.0-112.7)c NR 20 (71.4) 2 (9.5) 9 (32.1) 10 U 7 TP: 7 Infrarenal: 7 0 (0.0) Phade, 201135 R+SC 531 (3.0) 16 E 15 73 (41-84)b 15 (94) RP: 3 TP: 13 Supraceliac: 12, Suprarenal: 3, Infrarenal:1 29a NR NR 1 (6.7) 4 (25.0) 4 U 1 1 (100) Pitoulias, 200936 R+SC 625 (6.2) 39 E 34 70.2±6.3 32 (82.1) TP: 34 Infrarenal: 36, NR: 3 NR 57.1±8.1 3 (7.7) 3 (8.8) 4 (10.3) 5 U 5 TP: 5 39±5.1 1 (20) Scali, 201437 Case-control R+SC 873 (6.2) 25 E 25 72.8±10.0 20 (80) RP: 14 TP: 11 Supramesenteric: 9, Suprarenal: 11, Infrarenal: 5 27 (10-63) 72±17 4 (16) 1 (4) 4 (16.0) 14 Tiesen-hausen, 200638 R+SC 114 (22.8) 26 E 20 67.6 (50.6-79.7)b 17 (85) RP: 3 TP: 16 TL: 1 Supraceliac: 1, Suprarenal: 1, Infrarenal: 18 42.1 (0.03-80.4)b NR 13 (50) 0 (0.0) 3 (11.5) 4 U 6 71.7 (62.9-77.6)b 5 (83.3) TP: 6 Infrarenal: 6 31.3 (0.03-61.5)b 3 (50) Turney, 201418 R+SC 1881 (5.3) 100 E 71 75 (50-93)b 91 (91) RP: 56 TP: 44 Supraceliac: 54, Suprarenal: 33, Infrarenal: 13 41 (1-144)c NR 22 (22) 7 (9.9) 17 (17.0) 4 U 29 10 (34.5)
9
Table 9.1. continued
Study Study type La
te
conversions per total EV
AR
performed Total la
te
conversions, N E/U N Age, years Male sex Surgical approach Clamp loca
tion
Time implant to conversion, mo AAA size a
t
conversion, mm Partial explant 30-day mortality ra
te Overall mortality ra te MINORS Verzini, 200639 R+SC 649 (4.5) 29 E 25 NR 25 (86) RP: 5 TP: 24 Suprarenal: 12, Infrarenal: 16, NR: 1 33 (7-85 )c 60 (35-100)c 2 (6.9) 0 (0.0) 2 (6.9) 8 U 4 0 (0.0) Vries de, 200540 R+SC 355 (2.8) 10 E 6 66.5 (56-73)c 6 (100) TP: 6 Supraceliac: 6 4.5 (1-59)c NR 0 (0) 0 (0.0) 2 (20.0) 7 U 4 77 (68-87)c 4 (100) TP: 4 Supraceliac: 4 45.5 (18-50)c 2 (50) Wu, 201541 R+SC 1729 (4.5) 77 E 71 73.1 (54-86)b 62 (80.5) TP: 77 Supraceliac: 38, Suprarenal: 20, Infrarenal: 19 28 (4-83)b 61 (48-115)b 0 (0) 1 (1.4) 4 (5.2) 4 U 6 3 (50)
AAA, Abdominal aortic aneurysm; BS, bilateral subcostal; E, elective; EVARs, endovascular aneurysm repairs; IN, indistinguishable/unclear; MC, multicenter; MINORS, Methodological Index for Non-Randomized Studies; NR, not reported; R, retrospective; RP, retroperitoneal; SC, single center; T, transverse incision;
TL, thoracophrenic laparotomy; TP, transperitoneal; U, urgent. Data are reported as mean ± standard deviation, median (interquartile range), or number (%), unless otherwise indicated.
aValue represents mean, range, or mean ±2 standard deviations
bValue represents mean (range)
cValue represents median (range)
dNumber enrolled in study, not center.
eMulticenter, incidence at 8 centers.
Table 9.1. continued
Study Study type La
te
conversions per total EV
AR
performed Total la
te
conversions, N E/U N Age, years Male sex Surgical approach Clamp loca
tion
Time implant to conversion, mo AAA size a
t
conversion, mm Partial explant 30-day mortality ra
te Overall mortality ra te MINORS Verzini, 200639 R+SC 649 (4.5) 29 E 25 NR 25 (86) RP: 5 TP: 24 Suprarenal: 12, Infrarenal: 16, NR: 1 33 (7-85 )c 60 (35-100)c 2 (6.9) 0 (0.0) 2 (6.9) 8 U 4 0 (0.0) Vries de, 200540 R+SC 355 (2.8) 10 E 6 66.5 (56-73)c 6 (100) TP: 6 Supraceliac: 6 4.5 (1-59)c NR 0 (0) 0 (0.0) 2 (20.0) 7 U 4 77 (68-87)c 4 (100) TP: 4 Supraceliac: 4 45.5 (18-50)c 2 (50) Wu, 201541 R+SC 1729 (4.5) 77 E 71 73.1 (54-86)b 62 (80.5) TP: 77 Supraceliac: 38, Suprarenal: 20, Infrarenal: 19 28 (4-83)b 61 (48-115)b 0 (0) 1 (1.4) 4 (5.2) 4 U 6 3 (50)
AAA, Abdominal aortic aneurysm; BS, bilateral subcostal; E, elective; EVARs, endovascular aneurysm repairs; IN, indistinguishable/unclear; MC, multicenter; MINORS, Methodological Index for Non-Randomized Studies; NR, not reported; R, retrospective; RP, retroperitoneal; SC, single center; T, transverse incision;
TL, thoracophrenic laparotomy; TP, transperitoneal; U, urgent. Data are reported as mean ± standard deviation, median (interquartile range), or number (%), unless otherwise indicated.
aValue represents mean, range, or mean ±2 standard deviations
bValue represents mean (range)
cValue represents median (range)
dNumber enrolled in study, not center.
eMulticenter, incidence at 8 centers.
Figure 9
.2.
Graphic r
epr
esenta
tion o
f the total number o
f la
te conversions (ur
gent and elective) with the mortality ra
te per study and the timeframes
during which the da
ta wer
e r
eviewed.
Table 9
.2.
Methodological quality o
f the included studies.
Methodological item for non-randomized studies 1. Clearly sta
ted aim 1 2 1 2 1 2 1 2 1 2 2 1 1 1 1 1 1 1 2 1 1 2 2 1 2 1 1 2. Inclusion o f consecutive pa tients 1 1 1 1 1 1 1 1 1 2 1 2 1 1 2 2 2 1 2 1 2 2 1 1 2 1 2 3 . Pr ospective collection o f da ta 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 . Endpoints appr opria te to the aim o f the study 1 2 1 2 2 2 2 2 1 2 2 2 2 1 1 1 1 1 2 1 1 2 1 1 1 1 1 5. Unbiased assessment o
f the study endpoint
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6
. Follow-up period appr
opria te to the aim o f the study 1 2 1 2 2 1 2 2 0 2 2 2 1 2 2 2 2 2 2 1 1 2 0 1 2 2 0 7. Loss to f
ollow-up less than 5%
1 1 0 0 0 0 1 2 0 2 0 0 0 2 1 0 0 1 2 0 0 1 0 0 1 2 0 8 . Pr ospective calcula tion o
f the study siz
e 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Additional criteria in the case o
f compara tive studies 9 . adequa te contr ol gr oup 1 10 . Contemporary gr oups 1 11. Baseline equivalence o f gr oups 1 12. Adequa te sta tistical analysis 2 Total 5 8 4 7 6 6 7 9 3 10 7 7 5 7 7 6 6 6 10 4 5 14 4 4 8 7 4 Items wer e scor ed 0 (not r eported), 1 (r
eported but inadequa
te), or 2 (r
eported and adequa
te). Arya, 201344 Ben Abdallah, 201745 Böckler, 200246 Bonardelli, 201843 Brewster, 200626 Brinster, 201147 Chaar, 201219 Ferrero, 201348 Jacobowitz, 199927 Kansal, 201828 Klonaris, 201429 Kong, 200530 Lipsitz, 200325 Marone, 201331 Menna, 201532 Millon, 200933 Nabi, 200913 Phade, 201135 Pitoulias, 200936 Scali, 201437 Tiesenhausen, 200638 Turney, 201418 Verzini, 200639 Vries de, 200540 Wu, 201541 Perini, 201734 Joo, 201842
9
Indications for conversion
The indications for late open conversion are summarized in Table 9.3. The most
common indications for late conversion were endoleak (62.2%; 95% CI, 58.8%-65.6%),
aneurysm rupture (11.1%; 95% CI, 8.9%-13.3%), infection (8.1%; 95% CI, 6.2%-10.0%), and
endotension, defined as aneurysm expansion without a detectable endoleak (5.8%; 95%
CI, 4.2%-7.4%). A total of 498 (80.7%) of the elective conversions were performed for
endoleaks, whereas urgent conversions were mostly performed for rupture (85 [48.9%]).
Aneurysm size at conversion was a median of 61.5 mm (IQR, 58.3-70.8 mm) but it was
not reported in 39.2% of the patients. The most commonly explanted endografts were
Excluder (W. L. Gore & Associates, Flagstaff, Ariz) in 16.2% (95% CI, 13.6%-18.8%), Talent
(Medtronic, Minneapolis, Minn) in 14.5% (95% CI, 12.1%-17.0%), AneuRx (Medtronic) in
13.7% (95% CI, 10.7%-16.6%), and Zenith (Cook, Bloomington, Ind) in 13.0% (95% CI,
10.7%-15.4%). The type of endograft was not reported in 97 patients (12.3%; Table 9.4).
Secondary endovascular salvage procedures before late conversion were reported in
29.7% (95% CI, 26.5%-32.9%) but were not reported or were reported for an entire EVAR
population in nine studies.
18,26,28,34,36,38,42,44,46Of the 21 studies reporting on endovascular
salvage procedures, 68% of procedures were unsuccessful and led to open conversions.
No details could be identified for the remaining 32%.
Surgical details
The surgical approach was transperitoneal in 585 patients (74.0%; 95% CI,
70.9%-77.0%) and retroperitoneal in 119 (15.0%; 95% CI, 12.6%-17.5%). Subcostal incisions
were used in three patients (0.4%), a transverse incision was made in seven (0.9%), and
a thoracophrenico laparotomy was performed in two (0.3%). The surgical approach
was not reported in 75 patients (9.5%; 95% CI, 7.4%-11.5%).
Surgical clamping was supraceliac in 22.9% of patients (95%, CI 20.0%-25.8%),
supramesenteric in 1.3% (95% CI, 0.5%-2.0%), suprarenal in 23.3% (95% CI,
20.3%-26.2%), and infrarenal in 36.3% (95% CI, 32.9%-39.6%). Juxtarenal clamping was
performed in five patients (0.6%), the graft was clamped in one patient (0.1%), and an
endoballoon was used in one patient (0.1%). The exact location of surgical clamping
was not reported in 12.3% (95% CI, 10.0%-14.5%) of the conversions. In 25 patients
(3.2%; 95% CI, 1.9%-4.4%), no surgical clamping was performed: the endograft was
preserved and type II endoleaks were treated through laparotomy.
Complete endograft explantation was performed in 478 patients (60.4%; 95% CI,
57.0%-63.8%), and partial endograft explantation was performed in 218 patients (27.6%;
95% CI, 24.5%-30.7%). In 86 patients (10.9%; 95%, CI 8.7%-13.0%) the type of explantation
was not reported or the endograft was preserved and type II endoleaks were treated
through aortotomy.
Table 9.3. Primary indications for late open conversion.
Indication Total (n=791) Elective (n=617) Urgent (n=174)
De novo aneurysm Distal aneurysm 1 (0.1) 0 (0.0) 1 (0.6) Visceral aneurysm 5 (0.6) 5 (0.8) 0 (0.0) Aortoduodenal fistula 3 (0.4) 2 (0.3) 1 (0.6) Aortoenteric fistula 7 (0.9) 2 (0.3) 5 (2.9) Endoleak Type I (unknown whether A or B) 70 (8.8) 56 (9.1) 14 (8.0) Type IA 103 (13.0) 99 (16.0) 4 (2.3) Type IB 34 (4.3) 33 (5.3) 1 (0.6) Type II 99 (12.5) 92 (14.9) 7 (4.0) Type III 37 (4.7) 33 (5.3) 4 (2.3) Type IV 2 (0.3) 1 (0.2) 1 (0.6) Type V (Endotension) 46 (5.8) 46 (7.5) 0 (0.0)
Endoleak, unclassified 147 (18.6) 138 (22.4)a 9 (5.2)
Graft
Infolding and collapse 1 (0.1) 1 (0.2) 0 (0.0)
Kinking 3 (0.4) 1 (0.2) 2 (1.1) Thrombosis 37 (4.7) 31 (5.0) 6 (3.6) Occlusion 13 (1.6) 9 (1.5) 4 (2.3) Malposition 5 (0.6) 4 (0.6) 1 (0.6) Migration 18 (2.3) 15 (2.4) 3 (1.7) Infection 64 (8.1) 38 (6.2) 26 (14.9) Peripheral emboli 1 (0.1) 1 (0.2) 0 (0.0) Prophylactic 2 (0.3) 2 (0.3) 0 (0.0) Rupture 88 (11.1) 3 (0.5) 85 (48.9) Unclear 5 (0.6) 5 (0.8) 0 (0.0)
Data are presented as numbers (percentage).
aTwo patients with type I and type II endoleaks, two patients with a type IA endoleak and either type IB or type II
endoleak, one patient with a type II and type III endoleak. Four patients comprised type I in two, type II in one, type III in one, and type V in one.
bOne patient also had a type III endoleak
The follow-up after conversion was reported in 19 studies and lasted a mean of 28.1
months (95% CI, 20.5-35.9 months; range, 0.1-180.0 months). Temporary or permanent
hemodialysis was required in 3.9% (95% CI, 2.6%-5.2%) but was not reported in 11
articles. The complication rate was 36.7% (95% CI, 27.0%-46.4%) for a combination
of urgent and elective late conversions (Table 9.5). The overall mortality rate during
follow-up was 16.8% (95% CI, 14.2%-19.4%).
Table 9.4. Type of aortic endografts implanted during the primary endovascular aneurysm repair
procedure.
Endograft No (%) Excludera 128 (16.2) Talentb 115 (14.5) AneuRxb 108 (13.7) Zenithc 103 (13.0) Vanguardd 78 (9.9) Ancuree 39 (4.9) Endurantb 29 (3.7) EVTf 24 (3.0) Anacondag 23 (2.9) Powerlinkh 12 (1.5) Nellixh 7 (0.9) Homemade endografts 7 (0.9) Fortroni 4 (0.5) Lifepathj 4 (0.5) Ovationk 3 (0.4) AFXh 2 (0.3) Quantumi 2 (0.3) Stentord 2 (0.3) Renuc 1 (0.1) Seall 1 (0.1) Setam 1 (0.1) Treovancen 1 (0.1) Not reported 97 (12.3)aW. L. Gore & Associates, Flagstaff, Ariz.
bMedtronic, Minneapolis, Minn.
cCook, Bloomington, Ind.
dBoston Scientific Ltd, St Albans, Herts, UK.
eGuidant, Indianapolis, Ind.
fEndoVascular Technologies, Menlo Park, Calif.
gVascutek, Ltd, Inchinnan, UK.
hEndologix, Irvine, Calif.
iCordis Corp, Johnson & Johnson, Miami, Fla, USA.
jEdwards Lifesciences, Irvine, Calif.
kTrivascular Inc, Santa Rosa, Calif.
lS&G Biotech, Seoul, Korea.
mLatecba, Buenos Aires, Argentina.
nBolton Medical, Barcelona, Spain.
Table 9.5. Reported complications of the included studies
Study Complication rate (%) Defined as Complications (n) Arya, 201344 30.8a 30-day major morbidityAny postoperative complication resulting in prolonged length of stay, disseminated intravascular coagulopathy, multisystem organ failure, need for re-exploration, dialysis-dependent renal failure, ventilator dependence, myocardial infarction requiring revascularization, limb loss, stroke or spinal cord ischemia: 12
Ben Abdallah, 201745 42.0 Overall incidence of moderate to severe complications Renal: 6 Pulmonary: 5 Gastrointestinal: 2 Hemorrhagic: 5 Re-intervention: 46 Böckler, 200246 14.0a Procedure-related complications Wound infection: 3 Peripheral embolism: 1 Chylous ascites: 1 Bonardelli, 201843 8.3 Major complications
Multiple organ failure: 2
Not included in complication rate
Renal: 5
Myocardial infarction: 1 Stroke: 1
Brewster,
200626
Indistinguishable Indistinguishable Indistinguishable (reported for the entire cohort of patients receiving EVAR)
Brinster,
201147
14.0 Major
complications
Lower extremity ischemia: 1 Gastrointestinal: 2 Chaar, 201219 55.0 Overall morbidity Renal: 10 Bleeding: 9 Wound infection: 2 Pneumonia: 11 Urinary tract infection: 3 Myocardial infarction: 2 Gastrointestinal: 2 Femoral pseudoaneurysm: 1 Lower extremity thrombosis: 1 Return to OR: 8 Ferrero, 201348 38.4a Major non-fatal morbidity Pneumonia: 1 Atrial fibrillations: 2 Renal: 2 Bowel perforations: 2 Pancreatitis: 2 Angina pectoris: 1 Jacobowitz, 199927 45.8a Perioperative morbidity Renal: 2 Pulmonary: 4 Myocardial infa rction: 1 Wound infection: 2 Death: 2
Table 9.5. continued
Study Complication rate (%) Defined as Complications (n) Joo, 201842 20.0 30-day major morbidityUnclear which were included as major morbidity
Renal: 3 Pulmonary: 4 Myocardial infarction: 1 Reoperation for bleeding: 3 Gastrointestinal: 1 Kansal, 201828 62.5 Major in hospital complications, any life threatening sequelae following surgery or death Renal: 4 Pneumonia: 1 Hemothorax: 1 Delirium: 3 Gastrointestinal: 1 Urinary tract infection: 2 Urinary retention: 1 Cardiac: 3 Leg paresthesia: 1
Post-conversion major surgical re-intervention: 1 Klonaris, 201429 11.1 Major perioperative complications and prolonged intensive care unit and hospital stay Cardiac: 1 Pulmonary infection: 1 Kong, 200530 NR NR NR Lipsitz 200325 27.0 Perioperative morbidity Myocardial infarction: 1 Gastrointestinal: 1 Marone, 201331 31.0 Overall systemic morbidity Renal: 13 Pulmonary: 3 Myocardial infarction: 1
Not included in complication rate
Bleeding: 3
Lower extremity ischemia: 3 Gastrointestinal: 3 Menna, 201532 23.0 Non-fatal perioperative complications Renal: 3 Pulmonary: 2 Myocardial infarction: 1 Millon, 200933 50.0 Major non-lethal morbidity Renal: 6 Myocardial infarction: 1 Lower extremity ischemia: 1 Nabi,
200913
8.3 Morbidity
(only elective conversions)
Significant intraoperative blood loss: 1
Table 9.5. continued
Study Complication rate (%) Defined as Complications (n) Perini, 201734 38.5 Overall systemic morbidity Renal: 2 Pulmonary: 5 Myocardial infarction: 2 Gastrointestinal: 1 Phade, 201135 56.0 Perioperative complications Renal: 6 Pulmonary: 5 Pneumonia: 2 Myocardial infarction: 2 Lower extremity ischemia: 2 Deep venous thrombosis: 2 Hemorrhage: 2 Gastrointestinal: 2 Pitoulias, 200936 56.0 Post-conversion life-threatening morbid conditions requiring aggressive medical or surgical management with prolonged intensive care and total hospital stay Renal: 6 Pulmonary: 4 Myocardial infarction: 2 Gastrointestinal: 3Retroperitoneal hematoma requiring drainage: 6 Distal embolization: 1 Scali, 201437 60.0 Any major or minor complication (only elective) Renal: 7 Cardiac: 9 Pulmonary: 5 Bleeding: 2 Gastrointestinal: 1 Stroke/TIA or delirium: 1
Ancillary postoperative procedure: 2 Tiesenhausen,
200638
NR NR Renal: 2 (only reported for urgent late conversions)
Turney, 201418 44.0 No clear definition, any complication Renal:9 Cardiac: 29 Pulmonary: 26 Any complication: 44 Verzini, 200639 20.7 Major non-fatal morbidity Pneumonia: 2 Cardiac: 1 Renal: 1
Bleeding requiring transfusion: 1 Inguinal infection: 1
Table 9.5. continued
Study Complication rate (%) Defined as Complications (n) Vries de, 200540 70.0 No clear definition, complications Renal: 1 Pneumonia: 1 Compartment syndrome: 1 Splenectomy: 1Urosepsis and gastritis: 1 Death: 2
Wu,
201541
NR NR Renal: 1
EVAR, Endovascular aneurysm repair; NR, not reported; OR, operating room; TIA, transient ischemic attack.
aNot included in overall complication rate for late open conversions because they reported the complication
rate for both early and late conversions.
Pooled data
The meta-analysis of the studies demonstrated that the pooled estimate for 30-day
mortality rate for elective late conversions was 2.8% (95% CI, 1.6%-4.1%; P = .798). No
heterogeneity was observed between the studies (I
2= 0%, Figure 9.3). For urgent late
conversions, the estimated pooled 30-day mortality rate was 28.3% (95% CI,
20.4%-36.2%; P = .025). There was moderate heterogeneity between the studies (I
2= 39.0%,
Figure 9.4). The difference between the 30-day mortality rates of elective and urgent
late conversions was significant (P < .001).
DISCUSSION
This meta-analysis found the 30-day mortality rate of late urgent conversions in
failed EVAR is 10 times higher compared with late elective conversions (28.3% vs
2.8%). However, the scientific quality of the available literature is low. Kouvelos et
al.
20systematically reviewed late conversions after failed EVAR in 2014. In this
meta-analysis, 10 manuscripts (156 patients) were added, and 9 studies with a small number
(<10) of patients were excluded. Moreover, urgent and elective late conversions were
analyzed separately.
The greatest pitfall of EVAR remains the occurrence of endoleaks. The most
common types reported in the included studies were type I (207 [26.2%]) and type
II endoleaks (99 [12.5%]). Type II endoleaks can be treated conservatively in case of
a shrinking or stable aneurysm.
49Aneurysm growth may increase the risk of adverse
events, but whether this leads to an increased risk of rupture remains controversial.
The Society of Vascular Surgery and the European Society for Vascular Surgery
9
both recommend treatment of type II endoleaks that are associated with aneurysm
sac expansion.
49,50It is recommended that a type II endoleak with a sac increase of
>10 mm be treated endovascularly or laparoscopically. If these reinterventions fail,
conversion to open surgery will be the next step.
49Endovascular salvage procedures
before conversions were performed in ~30% of the patients but were only reported in
18 studies. Of these, 68% were reported to be unsuccessful.
Another common reason for conversion was endotension (5.8%), which was
reported in 18 studies. Endotension was defined in 12 of the 18 studies as aneurysm
expansion without a detectable endoleak
25–28,30,34,36,42,44,45,47,48in accordance with the
Society for Vascular Surgery and European Society for Vascular Surgery guidelines
49,50but was not defined in 6 studies.
18,19,32,39,41,43To date, there is no consensus about the
exact cause of endotension when no endoleak is found, but endotension is reported in
late conversions was significant (P < .001).
Figure 9.3. Forest plot of the pooled 30-day mortality rate for elective late conversion. The solid
squares indicate the mean difference and are proportional to the weights used in the
meta-analysis. The dashed line indicates the summary measure with the associated diamond indicating
the weighted mean difference and the lateral tips of the diamond indicating the associated
confidence intervals (CIs). The horizontal lines represent the 95% CI. Ev/Trt, Events/treated.
up to 5% of cases treated by EVAR.
51Some authors argue that endotension means that
there is an unclassified endoleak and further imaging is required. Alternative imaging
modalities, such as delayed-phase computed tomography scans, contrast-enhanced
duplex ultrasound imaging, or blood pool agents with magnetic resonance imaging,
may be able to detect these low-flow endoleaks.
52–54Endograft infection as an indication for conversion was reported in 16
articles.
18,19,26,28,30–33,35,41–45,47,48Infection was present in 64 patients (8.1%), 38 (6.2%) and
26 (14.9%) in an elective and urgent setting, respectively. The incidence for endograft
infections in this review was 0.4% (i.e., excluding five studies that did not report data
on center incidence of EVAR), which relates to that reported in a systematic review by
Argyriou et al.
55According to their review, the 30-day mortality rate after conversion for
Figure 9.4. Forest plot of the pooled 30-day mortality rate for urgent late conversion. The solid
squares indicate the mean difference and are proportional to the weights used in the
meta-analysis. The dashed line indicates the summary measure with the associated diamond indicating
the weighted mean difference and the lateral tips of the diamond indicating the associated
confidence intervals (CIs). The horizontal lines represent the 95% CI. Of note, Scali et al and Nabi
et al did not report on urgent late conversions. Ev/Trt, Events/treated.
infection was 26.6%. Unfortunately, the 30-day mortality rate could not be determined
in this study because separate data per indication for conversion were rarely reported
for the infection subgroup.
Despite the advent of more complex endovascular bailout procedures, such as
EndoAnchors, fenestrated and branched or chimney EVAR, and coil and Onyx (ev3,
Irvine, Calif) embolization,
56conversion rates after failed EVAR have gradually increased
over time. Conversion rates of 1.9% in 2010, and 4.0% in 2015 were reported
17,20,
increasing to 5.4% in this meta-analysis (data not reported in six studies). The reported
incidence comprised all late conversions that were performed, including referrals
from other centers. Although improvements have been made in the endografts
and in preoperative and perioperative imaging, physicians seem to be pushing the
endovascular envelope, which may explain the increase in explantations during last
decade.
A major limitation of the studies is that they are all retrospective reviews. In addition,
the methodologic quality of the studies was mostly low, despite exclusion of case
reports of <10 patients. Interestingly, newer studies roughly had higher MINORS scores
compared with earlier reports, which may be because of better defined end points of
the studies and more appropriate follow-up imaging and time (possibly because of
review of records during a longer time).
When the data from elective late conversion groups are compared with historic
elective open AAA repair data, the 30-day mortality rate of 2.8% in this meta-analysis
is comparable; that is, elective open AAA repair is associated with a pooled 30-day
mortality rate of 4.2% according to a meta-analysis by Paravastu et al.
57, and more
recent studies reported 30-day mortality rates of up to 2.4%.
7–11The mortality rate of 28.1% for urgent late open conversion in this review lies well
within the range of primary urgent open surgical repairs of 22.9% and 39.3%.
7,9,58–60The
30-day mortality rates are comparable to primary open surgical AAA repairs. If a late
open conversion is needed, elective open conversion is a valuable treatment option
and should be considered to prevent a necessary urgent conversion. Nonetheless,
treatment choice should be carefully decided on the basis of individual patients’ life
expectancy, clinical risk factors, and anatomic requirements for EVAR; in addition, costs
for reinterventions during follow-up should be considered. The results of this
meta-analysis can be used to inform the patient of the risk associated with late conversion
after primary EVAR.
Limitations
The inclusion criteria in this systematic review were strict to reduce heterogeneity of
the included studies, which was achieved for the pooled 30-day mortality rate of the
elective cases. Nevertheless, heterogeneity existed for the pooled data analysis of the
urgent cases, possibly related to the methodologic quality of the included studies.
Notably, there were three studies with a 100% 30-day mortality for urgent conversions.
A selection bias may be present because of the retrospective character of the included
studies. Moreover, treatment bias and the mixture of indications of conversions
(e.g., ruptured/symptomatic aneurysms, infections, thrombosis causing lower limb
ischemia) may have contributed to the heterogeneity in the urgent setting. Moreover,
some deaths may have been missed or not reported back to the original investigators.
Furthermore, the meta-analysis was performed only for the primary outcome because
of mixed reporting of other outcome variables in most of the studies. Some endografts
may be more technically demanding to explant than others. Especially, endografts with
suprarenal fixation and anchoring pins or hooks make conversions more challenging.
The effect on the primary outcome or risk of postoperative complications of hostile
neck criteria, surgical approach (transperitoneal or retroperitoneal), clamp location
(suprarenal, juxtarenal, or infrarenal), type of explantation (partial or complete), or
endograft type could not be determined in this review, nor could the effect of the
surgeon’s and center’s volume of explantations be determined. No separate analysis
could be performed without the 35 patients whose endografts were preserved (in case
of type II endoleaks).
CONCLUSION
Type I endoleak and rupture are the most common indications for, respectively,
elective and urgent conversions. The 30-day mortality rate was 10 times higher for
patients treated with late open conversions in an urgent vs elective setting. The
30-day mortality rate of elective late open conversions is almost comparable to that of
primary elective open AAA repair procedures. For the interpretation of the outcomes
of the review, however, the methodologic quality of the available literature should be
considered.
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