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A systematic review and meta-analysis of long-term reintervention after endovascular abdominal aortic aneurysm repair
From the Society for Vascular Surgery
A systematic review and meta-analysis of long-term reintervention after endovascular abdominal aortic aneurysm repair Zachary J. Wanken, MD, MS,a,b J. Aaron Barnes, MD,a Spencer W. Trooboff, MD, MBA,b Jesse A. Columbo, MD, MS,a Tarun K. Jella, MPH,b Daniel J. Kim, MPH,b Arian Khoshgowari, MPH,b Natalie B. V. Riblet, MD, MPH,b and Philip P. Goodney, MD, MS,a,b Lebanon and Hanover, NH
ABSTRACT Objective: Patients who undergo endovascular aneurysm repair (EVAR) often require reintervention after the index repair. The long-term rate of reintervention and how this has changed with newer device technology are poorly understood. Therefore, we performed a systematic review and meta-analysis of the available literature to determine longterm freedom from reintervention after EVAR and the change in reintervention rates over time. Methods: We performed a systematic review of MEDLINE, Embase, Cochrane Library, and ClinicalTrials.gov in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included randomized controlled trials and observational studies that documented the rate of reintervention after EVAR. We performed a metaanalysis of Kaplan-Meier freedom from reintervention at each year after EVAR. We used linear regression to evaluate change in reintervention rate over time with newer device technology. Results: We included a total of 30 studies (randomized trials, n ¼ 3; observational studies, n ¼ 27) comprising 32,126 patients in this review and meta-analysis. Studies ranged in the implantation date of the EVAR device from 1996 to 2014. The probability of freedom from reintervention was 81% (95% confidence interval [CI], 77%-85%) at 5 years, 70% (95% CI, 65%76%) at 10 years, and 64% (95% CI, 46%-79%) at 14 years. Linear regression demonstrated an improvement in freedom from reintervention when results were stratified by the year of device implantation. At 1 year, estimated freedom from reintervention improved from 90% in 1998 to 94% in 2008 (n ¼ 26 studies; R2 ¼ 0.11; P ¼ .10). At three years, estimated freedom from reintervention improved from 77% in 1998 to 90% in 2008 (n ¼ 26 studies; R2 ¼ 0.27; P ¼ .006). At 5 years, estimated freedom from reintervention improved from 68% in 1998 to 81% in 2008 (n ¼ 22 studies; R2 ¼0.12; P ¼ .12). At 7 years, estimated freedom from reintervention improved from 51% in 1998 to 86% in 2011 (n ¼ 22 studies; R2 ¼ 0.40; P ¼ .015). Conclusions: EVAR patients remain at risk for reintervention indefinitely, and therefore lifelong surveillance is imperative. Encouragingly, reintervention rates have improved over time, with newer devices exhibiting lower rates. Reintervention rate remains an important metric for new devices and registries. (J Vasc Surg 2020;-:1-10.) Keywords: Abdominal aortic aneurysm; Endovascular aortic aneurysm repair; Reintervention
Abdominal aortic aneurysm (AAA) is a common disease, and rupture represents a life-threatening emergency with mortality approaching 90%.1,2 In the United States, ruptured AAA is the fourteenth leading cause of death.3 Major open surgery was traditionally required for repair.4 Since the early 2000s, however, there has been a major paradigm shift to endovascular aneurysm repair (EVAR).5 Now, nearly 80% of patients who are treated surgically for AAA will undergo EVAR. EVAR is associated with lower in-hospital morbidity and
mortality and a shorter hospital stay compared with traditional open surgical repair.6,7 The tradeoff between EVAR and open surgical repair is durability. In the 3 years after EVAR, up to one-fifth of patients require a reintervention procedure.7-10 Reinterventions include any secondary surgical or endovascular procedure pertaining to the EVAR device or AAA and may consist of minor catheter-based procedures as well as major surgical revision operations.7,10,11 Whereas many prior studies have documented reintervention
From the Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center,
Correspondence: Zachary J. Wanken, MD, MS, Section of Vascular Surgery, 3V,
Lebanona; and The Dartmouth Institute for Health Policy and Clinical Prac-
Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH
tice, Hanover.b
03766 (e-mail: [email protected]).
P.P.G. is supported by a grant from the American Heart Association, and Z.J.W.
The editors and reviewers of this article have no relevant financial relationships to
and J.A.B. are supported as research fellows under this grant. This publication
disclose per the JVS policy that requires reviewers to decline review of any
is the result of coursework completed through the support of this education
manuscript for which they may have a conflict of interest.
grant. The American Heart Association did not have any direct role in the
0741-5214
study or publication.
Published by Elsevier Inc. on behalf of the Society for Vascular Surgery.
Author conflict of interest: none.
https://doi.org/10.1016/j.jvs.2020.02.030
Presented in the poster competition at the 2019 Vascular Annual Meeting of the Society for Vascular Surgery, National Harbor, Md, June 12-15, 2019.
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procedures to be common after EVAR, changes in reintervention rates over time are less well described. Therefore, our understanding of reintervention in relation to progression of device technology and surgical technique is limited. Our objective was to use the available literature to document the long-term rate of reintervention after EVAR and to determine change in reintervention rate over time. To accomplish this, we completed a systematic review and meta-analysis characterizing reintervention after EVAR for infrarenal AAA. Patients, providers, and payers all stand to benefit from improved understanding of the long-term complication profile of EVAR.
METHODS Inclusion and exclusion criteria. Before conducting this review, we devised a protocol outlining our planned approach to the identification and selection of studies. In doing this, we adhered to standard methodology for the analysis outlined by the Cochrane Handbook and followed recommended guidelines from the Preferred Reporting Items for Systematic Reviews and MetaAnalyses statement.12,13 The original protocol and record of all protocol changes are available from the authors on request. We used the following inclusion criteria to determine study eligibility: randomized controlled trials or observational studies (study design) evaluating Kaplan-Meier freedom from reintervention procedure in patients who have undergone EVAR for infrarenal AAA with an average (reported mean or median) of 36 months of follow-up or more and published in the English language. Studies were excluded if they solely or disproportionately evaluated patients with ruptured AAA or anatomy outside of instructions for use. Studies focusing on patients with collagen vascular disorders, mycotic AAA, and inflammatory AAA were also excluded. Patients with complex branched and fenestrated repairs or chimney and snorkel grafting were excluded. Databases and search terms. We searched MEDLINE (inception-October 2018), Embase (inception-October 2018), Cochrane Library (inception-October 2018), and ClinicalTrials.gov (inception-October 2018) to identify published articles relevant to our research question. We used exploded Medical Subject Headings terms and keywords for the themes of aortic aneurysm and endovascular procedures. We combined these themes using the Boolean terms “AND” and “OR” as appropriate. We did not apply limits to our initial search but later excluded studies during abstract review that could not be obtained in the English language. Study selection. We compiled studies from each database search and removed duplicates using EndNote software (Clarivate Analytics, Philadelphia, Pa). We
2020
ARTICLE HIGHLIGHTS d
d
d
Type of Research: Systematic review and metaanalysis of published rates of reintervention procedures after endovascular aneurysm repair (EVAR) Key Findings: Up to 19% of EVAR patients will require a reintervention at 5 years, 30% at 10 years, and 35% at 14 years. However, reintervention rates have improved over time. Through 7 years of follow-up, the proportion of patients who do not require reintervention has improved from 50% in 1998 to 86% in 2008. Take Home Message: EVAR patients remain at risk for reintervention indefinitely. However, reintervention rates have improved over time, with newer devices exhibiting lower rates.
transitioned the resultant list of studies to Rayyan QCRI software (Qatar Computing Research Institute, Doha, Qatar) for title and abstract review.14 We next reviewed the full-text manuscripts of studies that passed title and abstract review. Each full-text manuscript was reviewed by at least two authors to determine final study eligibility. If there was disagreement on inclusion, a third author reviewed the manuscript to make the final inclusion decision. Our review process yielded several manuscripts that used overlapping data. For randomized controlled trials, we used the most recent for data collection and analysis, and we used earlier reports to determine inclusion eligibility or to gather demographic information as needed. For example, we identified multiple manuscripts for the EVAR 1 and Dutch Randomized Endovascular Aneurysm Management (DREAM) trials.15-23 For observational studies, we included the studies with the greatest number of patients or longest follow-up period for analysis. To assess methodologic quality, we used the Cochrane risk of bias tool for randomized controlled trials and the modified Newcastle-Ottawa Scale for nonrandomized studies.24,25 Outcome measures and data collection. Our primary outcome measure, freedom from reintervention procedure, was determined from published Kaplan-Meier tables or curves. Reintervention was categorized as any surgical or endovascular procedure occurring after the index operation and pertaining to the EVAR procedure. Reintervention procedures included minor catheter-based procedures as well as major surgical revisions.7,10,11 We categorized major reinterventions as those that required laparotomy or axillofemoral bypass or were performed for ruptured AAA. One study categorized reinterventions as “life-threatening,” and these were included in the major reintervention group.9 We extracted study data using a standardized data collection form. Data
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Fig 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram of study inclusion. K-M, Kaplan-Meier.
extraction was performed independently by at least two authors and cross-checked for accuracy. A third author reviewed discordant data as needed to ensure accuracy. For studies without a published life table, we used DigitizeIt software (I. Bormann, Braunschweig, Germany) to estimate the yearly Kaplan-Meier value directly from the published figure.26 Data synthesis. In our first analysis, we compiled Kaplan-Meier freedom from reintervention on a yearly basis after EVAR procedures. To report this, we performed a meta-analysis for each year using the metaprop command in Stata (StataCorp LP, College Station, Tex). For each year, studies were included if they reported the number of patients at risk for that year, and studies were excluded if they did not report the number of patients at risk. Six studies did not report the number of patients at risk for any time period and were excluded from analysis.27-32 For our secondary analysis, we used linear regression to examine the association between Kaplan-Meier freedom from reintervention and median year of EVAR implantation. We performed this analysis to evaluate the effect of improved devices, imaging, and technique on the need for reintervention procedures. We specifically examined snapshots of freedom from reintervention at 1 year, 3 years, 5 years, and 7 years after index EVAR. Two studies stratified analysis by urgency of repair.33,34 For these studies, we used the data from the group with elective repair and excluded the estimates for patients with urgent or emergent repair. We excluded studies that provided stratified outcomes for
other subgroup types.32,35-37 We similarly used linear regression to evaluate the change in proportion of major reinterventions over time.
RESULTS Search results and studies included for analysis. Our search yielded 4946 studies from MEDLINE, 2916 studies from Embase, 123 studies from Cochrane Library, and 91 studies from ClinicalTrials.gov. A total of 1152 studies were duplicated between these search methods and removed. An additional 6690 studies were removed through title and abstract review, and 234 studies were subjected to full-text review. We included a total of 30 studies in the final review.10,23,27-54 Our selection process is shown in our Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram (Fig 1). Table I outlines the study characteristics of our 30 included studies, which consisted of three randomized controlled trials and 27 observational studies. Studies are included from 11 countries spanning North America, Europe, and Asia. A total of 32,126 patients were included in our analysis with a range of 50 to 12,239 patients per individual study. The patients were predominantly elderly and male. Range of mean aneurysm size was 53 to 70 mm. Methodologic quality of included studies. Overall, the methodologic quality of our included studies was good, and reporting of outcomes was homogeneous (Table II). The definition of reintervention was remarkably similar across all studies. Attrition and censoring were considerable across all studies. However, there were
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Table I. Studies included in systematic review and meta-analysis Country
Procedural year range
No. of EVAR patients
Italy
2003-2007
160
72.3
150 (93.8)
France
1998-2008
162
74.7
157 (96.9)
57.1
United States
2003-2014
176
75.3 6 8.7
144 (81.8)
N/A
Bisdas, 2014
Germany
2007-2010
273
73 6 9
246 (90)
N/A
Broos, 2016
The Netherlands
1998-2012
Study Antonello, 2013 Bartoli, 2012 Beckerman, 2016
Chang, 2015
United States
2001-2009
Coppi, 2008
Italy
1997-2001
Deery, 2018 EVAR trial participants, 2005 Garg, 2015
Hammond, 2016
Age, years
Male
Aneurysm diameter, mm 61 6 5
773 (elective)
72.2 6 7.7
697 (90.2)
59 6 12
90 (ruptured)
73.4 6 8.5
73 (81.1)
70 6 18
12,239
75.1
50
10,384 (84.4)
N/A
72
49 (98)
58
United States
2011-2012
178
71
146 (82)
54.5
United Kingdom
1999-2003
166
76.8 6 6.2
141 (85)
64
United States
2002-2005
3944 (incomplete surveillance)
76.2 6 6.2
3324 (84.3)
N/A
3944 (complete surveillance)
76.4 6 6.3
3274 (83.0)
N/A
United Kingdom
Hobo, 2007
The Netherlands and Italy
Huang, 2015
United States
Kaladji, 2015
France
2007-2013 1996-2006 2000-2011 1998-2012
234
N/A
208 (88.9)
N/A
4031
72.1 6 7.7
3820 (94.8)
57.9 6 10.4
74 6 7.1
497 (86)
57 6 10
738 (endograft diameter <32 mm)
74.8 6 8.3
687 (93.1)
56.1 6 10.1
170 (endograft diameter >32 mm)
76 6 8.3
164 (96.5)
58 6 10.1
558
Kim, 2016
Korea
2007-2010
126
71 6 8
105 (83)
61 6 13
Lee, 2015
Canada
2000-2013
50
57.1
46 (92)
56.4
Makaroun, 2002
United States
1995-1998
242
N/A
N/A
Malas, 2017
United States
2006-2011
67
74.0 6 7.9
Mestres, 2010
Spain
1997-2000
Nagpal, 2007
Canada
1997-2001
61
Oranen, 2006
The Netherlands
1998-2005
56
Patel, 2018
United Kingdom
1999-2004
626
100
52 (77.6)
N/A 54.3 6 9.0
71.6
58 (95.1)
60.8
73 6 7.7
84 (84)
62 6 6.6
73 6 9
51 (91)
70.1 6 15.9
74.1 6 6.1
565 (90)
65 6 9 50
Italy
2000-2005
138
71.5 6 8.6
125 (91)
Vaaramaki, 2007
Finland
1997-1999
48
70
44 (92)
57
van Herwaarden, 2007
The Netherlands
1996-2003
212
71.3 6 7
197 (93)
59.1 6 10.6
van Schaik, 2017
Piffaretti, 2014
The Netherlands
2000-2003
173
70.7 6 6.6
161 (93)
60.6 6 9.0
Verzini, 2017
Italy
2000-2011
805
73.3 6 7.7
805 (91.3)
55.3
Wang, 2009
United States
N/A
100 (small AAA)
72.4 6 6.7
88 (88)
N/A
Japan
2007-2014
United States
1998-1999
Yamamoto, 2015 Zarins, 2006
87 (large AAA)
73.9 6 7.4
78 (90)
N/A
426
77.9 6 6.2
354 (83.1)
53.2 6 1.5
145 (small AAA)
71.3 6 7.1
131 (90)
N/A
461 (medium AAA)
73.4 6 7.6
406 (88)
N/A
317 (large AAA)
74.6 6 8.6
279 (88)
N/A
AAA, Abdominal aortic aneurysm; EVAR, endovascular aneurysm repair; N/A, not available. Categorical variables are presented as number (%). Continuous variables are presented as mean 6 standard deviation.
some important differences in cohort demographics between studies. Over time, the comorbidity burden of patients declined as EVAR became available to more
patients. Two studies35,42 relied on administrative claims data, which contrasted with trial, registry, or chart review data in our other included studies.
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Table II. Methodologic quality of included studies using the modified Newcastle-Ottawa Scale for nonrandomized studies and Cochrane risk of bias tool for randomized controlled trials Modified Newcastle-Ottawa Scale Individual assessment domains
Cohort studies
Representative cohort
Ascertainment of exposure
Assessment of outcomes
Length of follow-up
Completeness of follow-up
Overall risk of bias judgment
Antonello, 2013
Low
Low
Low
Low
Moderate
Low
Moderate
Low
Low
Low
Moderate
Low
Beckerman, 2016
Low
Low
Low
Low
Moderate
Low
Bisdas, 2014
Low
Low
Low
Low
Moderate
Low
Broos, 2016
Moderate
Low
Low
Low
Moderate
Low
Chang, 2015
Moderate
Low
Low
Low
Moderate
Low
Bartoli, 2012
Coppi, 2008
Low
Low
Low
Low
Moderate
Low
Deery, 2018
Moderate
Low
Low
Low
Moderate
Low
Garg, 2015
Low
Low
Low
Low
Moderate
Low
Hammond, 2016
Low
Low
Low
Low
Moderate
Low
Hobo, 2007
Low
Low
Low
Low
Moderate
Low
Huang, 2015
Moderate
Low
Low
Low
Moderate
Low
Kaladji, 2015
Moderate
Low
Low
Low
Moderate
Low
Kim, 2016
Moderate
Low
Low
Low
Moderate
Low
Lee, 2015
Moderate
Low
Low
Low
Moderate
Low
Makaroun, 2002
Low
Moderate
Low
Low
Low
Moderate
Malas, 2017
Low
Low
Low
Low
Moderate
Low
Mestres, 2010
Low
Low
Low
Low
Moderate
Low
Nagpal, 2007
Moderate
Low
Low
Low
Moderate
Low
Oranen, 2006
Low
Low
Low
Low
Moderate
Low
Piffaretti, 2014
Moderate
Low
Low
Low
Moderate
Low
Vaaramaki, 2007
Low
Low
Low
Low
Moderate
Low
van Herwaarden, 2007
Low
Low
Low
Low
Moderate
Low
Verzini, 2017
Low
Low
Low
Low
Moderate
Low
Wang, 2009
Low
Low
Low
Low
Moderate
Low
Yamamoto, 2015
Low
Low
Low
Low
Moderate
Low
Zarins, 2006
Low
Low
Low
Low
Moderate
Low
Cochrane risk of bias tool Individual assessment domains Randomized controlled trials
Random sequence generation
Allocation concealment
Blinding (participants and personnel)
Blinding (outcome assessment)
Incomplete outcome data
Selective reporting
Other bias sources
Overall risk of bias judgment
EVAR trial participants, 2005
Low
Low
High
Moderate
Low
Low
Low
Low
Patel, 2018
Moderate
Low
High
Moderate
Low
Low
Low
Low
van Schaik, 2017
Low
Low
High
Moderate
Low
Low
Low
Low
Meta-analysis of Kaplan-Meier freedom from reintervention. Fig 2 demonstrates long-term Kaplan-Meier freedom from reintervention as determined by our meta-analysis of yearly estimates. The probability of freedom from reintervention was 81% (95% confidence
interval [CI], 77%-85%) at 5 years (patients contributing to estimate, 4405; studies contributing to estimate, 16), with a range of 23% to 99% across studies. At 10 years, the probability of freedom from reintervention was 70% (95% CI, 65%-76%; patients, 364; studies, 8), with a range
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Fig 2. Compilation meta-analysis of Kaplan-Meier freedom from reintervention after endovascular aneurysm repair (EVR). Each yearly estimate is composed of all studies meeting inclusion criteria and reporting the number of patients at risk at that time point.
of 19% to 98% across studies. At 14 years, the probability of freedom from reintervention was 64% (95% CI, 46%79%; patients, 28; studies, 1). Linear regression of study year and freedom from reintervention. Fig 3 demonstrates linear regression of study year and freedom from reintervention. During the years of our included studies, we found improvement in freedom from reintervention at 1 year, 3 years, 5 years, and 7 years after index EVAR. At 1 year, estimated freedom from reintervention improved from 90% in 1998 to 94% in 2008 (n ¼ 26 studies; R2 ¼ 0.11; P ¼ .10). At 3 years, estimated freedom from reintervention improved from 77% in 1998 to 90% in 2008 (n ¼ 26 studies; R2 ¼ 0.27; P ¼ .006). At 5 years, estimated freedom from reintervention improved from 68% in 1998 to 81% in 2008 (n ¼ 22 studies; R2 ¼ 0.12; P ¼ .12). At 7 years, estimated freedom from reintervention improved from 51% in 1998 to 86% in 2011 (n ¼ 22 studies; R2 ¼ 0.40; P ¼ .015). Breakdown of reintervention types. A total of 18 studies provided granular data for evaluation of the types of reintervention that were required. The total number of reinterventions reported in these studies ranged from 6 to 124. The proportion of major reinterventions reported across these studies ranged from 0% to 62.5%. We found no significant relationship between the year of device implantation and proportion of major reintervention (Fig 4). Catheter-based reinterventions were much more common overall and ranged from 14.6% to 93.8% across the included studies.
DISCUSSION Endovascular repair of aortic aneurysms surged in popularity because of drastic improvements in shortterm morbidity and mortality. Concerns about durability of repair developed during a longer period as studies published long-term follow-up. In this systematic review and meta-analysis of the published literature, we found that EVAR patients remain at risk of reintervention indefinitely after the index operation. Through 14 years of available follow-up, our results demonstrate that patients are at persistent risk of reintervention. More than one-third of EVAR patients required a secondary procedure during follow-up. We encouragingly found, however, that fewer patients now require reintervention as technology and surgical technique have improved over time. For example, the cumulative number of patients requiring reintervention within 7 years of index EVAR has been cut in half. Our results support the current guidelines of the Society for Vascular Surgery, European Society for Vascular Surgery, U.S. Food and Drug Administration, American College of Cardiology, American Heart Association, and Society of Interventional Radiology, which recommend indefinite imaging and clinical follow-up after EVAR.55-58 There is simply no safe time to stop surveillance imaging in the healthy patient. Unfortunately, more than half of EVAR patients experience a lapse in follow-up surveillance within 5 years of repair.59-61 Thorough preoperative discussion is critical to identify patients’ preferences regarding tradeoffs in short-term complications for long-term durability. Patients who value durability or
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Fig 3. Linear regression demonstrating the association of median study year and freedom from reintervention at four different time points: 1 year, 3 years, 5 years, and 7 years after the index repair. EVR, Endovascular aneurysm repair.
Fig 4. Linear regression demonstrating the association of median study year and proportion of reinterventions classified as major. EVR, Endovascular aneurysm repair.
prefer not to return for follow-up appointments may benefit from open surgical repair rather than EVAR. Patients with significant comorbidity burden should also be chosen carefully for EVAR as many of these patients will require multiple operations and therefore repeated risk of anesthesia and operative stress. Despite current concerns and considerations for patients in need of AAA repair, we are encouraged by the improvement in durability seen over time and believe there are several contributing factors. As with any new
procedure, surgeons experienced an initial learning curve to become facile with EVAR technology and its limitations.62 Second, device technology has improved through advances in endograft engineering and design.63 Third, case planning and execution have benefited from advances in imaging modalities, especially three-dimensional reconstructive software and hybrid operating rooms with fixed imaging systems.64,65 Modern surgeons have the capability to fully plan and to execute the case in virtual reality before even seeing the patient.66 It is difficult to predict which technologic advances might decrease the need for reintervention even further. Current device design, imaging, and surgeon skill, however, have pushed endovascular aortic repair beyond the infrarenal segment to include complex repairs of thoracoabdominal and arch aneurysms. In light of our findings, we encourage surgeons to focus on improving several specific aspects of aortic aneurysm care. For day-to-day clinical care, we recommend frank discussion to determine the patient’s preferences, weighing short-term benefits against long-term durability, which will help guide consideration of surgical AAA repair method. We recommend that device trials and registries maintain reintervention as an important metric for evaluation. A study by Hoshina et al67 illustrated the benefit of maintaining a robust registry, which allowed them to evaluate AAA repair outcomes in
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>38,000 patients throughout the country of Japan. Costeffectiveness is another important metric that stakeholders must continue to track. Reinterventions have been shown to cost the health care system an amount equivalent to the initial EVAR operation.68 Further improvements in reintervention rate would continue to improve the overall cost-effectiveness of EVAR compared with open surgical repair. Long term, we believe that ongoing collaboration between surgeons, engineers, and imaging specialists is critical and will further improve EVAR technology for broadened applications throughout aortic aneurysm care. We acknowledge limitations of our study. Our review was limited to the available literature and is susceptible to publication bias. Comorbidity burden of the patients included changed during the course of our study. Studies published in the early years of EVAR are composed of patients with higher comorbidity burden compared with later studies because EVAR was initially available primarily for use in patients physiologically unfit for traditional open repair.69 It is difficult to know how the improving health of EVAR patients over time may contribute to reintervention rates over time. We were also unable to evaluate outcomes for individual graft configurations. For example, the “build up” configuration used with the Endologix AFX (Endologix, Irvine, Calif) has been associated with high rates of type III endoleak and reintervention.70 Because of the heterogeneity of device use across studies, including many devices that are no longer on the market, we were unable to evaluate the individual effect of device construction. Last, we used studies that reported Kaplan-Meier freedom from reintervention and were unable to include studies that reported reintervention as a combined end point or did not include a Kaplan-Meier analysis.
CONCLUSIONS Patients who undergo EVAR remain at risk for reintervention indefinitely. For healthy patients, there is no safe time to be discharged from follow-up, and surveillance imaging should be continued indefinitely. Encouragingly, reintervention rates have improved over time with advances in device technology, aortic imaging, and surgical technique. Reintervention procedures remain an important benchmark in endograft device design and should remain an important focus of device trials and registries.
AUTHOR CONTRIBUTIONS Conception and design: ZW, ST, JC, TJ, DK, AK, NR, PG Analysis and interpretation: ZW, JB, ST, JC, TJ, DK, AK, NR, PG Data collection: ZW, JB, TJ, DK, AK Writing the article: ZW, TJ, DK, AK Critical revision of the article: ZW, JB, ST, JC, TJ, DK, AK, NR, PG
2020
Final approval of the article: ZW, JB, ST, JC, TJ, DK, AK, NR, PG Statistical analysis: ZW, ST Obtained funding: Not applicable Overall responsibility: ZW
REFERENCES 1. Norman PE, Powell JT. Abdominal aortic aneurysm: the prognosis in women is worse than in men. Circulation 2007;115:2865-9. 2. Assar AN, Zarins CK. Ruptured abdominal aortic aneurysm: a surgical emergency with many clinical presentations. Postgrad Med J 2009;85:268-73. 3. Aggarwal S, Qamar A, Sharma V, Sharma A. Abdominal aortic aneurysm: a comprehensive review. Exp Clin Cardiol 2011;16:11-5. 4. Thompson JE. Early history of aortic surgery. J Vasc Surg 1998;28:746-52. 5. Dua A, Kuy S, Lee CJ, Upchurch GR Jr, Desai SS. Epidemiology of aortic aneurysm repair in the United States from 2000 to 2010. J Vasc Surg 2014;59:1512-7. 6. Basoor A, Patel KC, Halabi AR, Todorov M, Senthilvadivel P, Choksi N, et al. Periprocedural and longterm outcomes of endovascular abdominal aortic aneurysm repair in cardiology practice. Catheter Cardiovasc Intervent 2014;84:1173-9. 7. Schermerhorn ML, Buck DB, O’Malley AJ, Curran T, McCallum JC, Darling J, et al. Long-term outcomes of abdominal aortic aneurysm in the medicare population. N Engl J Med 2015;373:328-38. 8. Al-Jubouri M, Comerota AJ, Thakur S, Aziz F, Wanjiku S, Paolini D, et al. Reintervention after EVAR and open surgical repair of AAA: a 15-year experience. Ann Surg 2013;258:652-7; discussion: 657-8. 9. Patel R, Sweeting MJ, Powell JT, Greenhalgh RM. Endovascular versus open repair of abdominal aortic aneurysm in 15years’ follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial. Lancet 2016;388:2366-74. 10. van Schaik TG, Yeung KK, Verhagen HJ, de Bruin JL, van Sambeek MR, Balm R, et al. Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms. J Vasc Surg 2017;66: 1379-89. 11. Paravastu SC, Jayarajasingam R, Cottam R, Palfreyman SJ, Michaels JA, Thomas SM. Endovascular repair of abdominal aortic aneurysm. Cochrane Database Syst Rev 2014;1: CD004178. 12. [updated March 2011] In: Higgns JP, Green S, editors. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration; 2011. Available at:, www.handbook.cochrane.org. Accessed November 2018. 13. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009;339:b2700. 14. Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyanda web and mobile app for systematic reviews. Syst Rev 2016;5:210. 15. Baas AF, Janssen KJ, Prinssen M, Buskens E, Blankensteijn JD. The Glasgow Aneurysm Score as a tool to predict 30-day and 2-year mortality in the patients from the Dutch Randomized Endovascular Aneurysm Management trial. J Vasc Surg 2008;47:277-81.
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16. Blankensteijn JD. Who to recommend for EVAR based on the long-term results of the DREAM trial. Journal of CardioVascular and Interventional Radiology 2017;40:S398-9. 17. De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, et al. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med 2010;362:1881-9. 18. de Bruin JL, Karthikesalingam A, Holt PJ, Prinssen M, Thompson MM, Blankensteijn JD. Predicting reinterventions after open and endovascular aneurysm repair using the St George’s Vascular Institute score. J Vasc Surg 2016;63: 1428-33.e1. 19. Majd P, Ahmad W, Becker I, Brunkwall JS. Ten-year singlecenter results of abdominal aortic aneurysm treatment: endovascular versus open repair. Ann Vasc Surg 2017;44: 113-8. 20. Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG. EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet 2004;364:843-8. 21. Brown LC, Powell JT, Thompson SG, Epstein DM, Sculpher MJ, Greenhalgh RM. The UK EndoVascular Aneurysm Repair (EVAR) trials: randomised trials of EVAR versus standard therapy. Health Technol Assess 2012;16:1-218. 22. Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D. Endovascular repair of aortic aneurysm in patients physically ineligible for open repair. N Engl J Med 2010;362:1872-80. 23. Patel R, Powell JT, Sweeting MJ, Epstein DM, Barrett JK, Greenhalgh RM. The UK endovascular aneurysm repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis. Health Technol Assess 2018;22:1-132. 24. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011;343: d5928. 25. Wells GA, Shea B, O’Connell D, Peterson J, Welch V, Losos M, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. Available at: http://www.ohri.ca/programs/clinical_epidemiology/ oxford.asp. Accessed November 2018. 26. Grootenboer N, Hunink MG, Hendriks JM, Van Sambeek MR, Buth J. Sex differences in 30-day and 5-year outcomes after endovascular repair of abdominal aortic aneurysms in the EUROSTAR study. J Vasc Surg 2013;58:42-9.e1. 27. Deery SE, Shean KE, Pothof AB, O’Donnell TF, Dalebout BA, Darling JD, et al. Three-year results of the Endurant stent graft system post approval study. Ann Vasc Surg 2018;50: 202-8. 28. Hammond CJ, Shah AH, Snoddon A, Patel JV, Scott DJ. Mortality and rates of secondary intervention after EVAR in an unselected population: influence of simple clinical categories and implications for surveillance. Cardiovasc Intervent Radiol 2016;39:815-23. 29. Makaroun MS, Chaikof E, Naslund T, Matsumura JS. Efficacy of a bifurcated endograft versus open repair of abdominal aortic aneurysms: a reappraisal. J Vasc Surg 2002;35:203-10. 30. Nagpal AD, Forbes TL, Novick TV, Lovell MB, Kribs SW, Lawlor DK, et al. Midterm results of endovascular infrarenal abdominal aortic aneurysm repair in high-risk patients. Vasc Endovascular Surg 2007;41:301-9. 31. Vaaramaki S, Pimenoff G, Heikkinen M, Suominen V, Saarinen J, Zeitlin R, et al. Ten-year outcomes after
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endovascular aneurysm repair (EVAR) and magnitude of additional procedures. Scand J Surg 2007;96:221-8. Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg 2009;43:244-51. Broos PP, ‘t Mannetje YW, Stokmans RA, Houterman S, Corte G, Cuypers PW, et al. A 15-year single-center experience of endovascular repair for elective and ruptured abdominal aortic aneurysms. J Endovasc Ther 2016;23: 566-73. Oranen BI, Bos WT, Verhoeven EL, Tielliu IF, Zeebregts CJ, Prins TR, et al. Is emergency endovascular aneurysm repair associated with higher secondary intervention risk at midterm follow-up? J Vasc Surg 2006;44:1156-61. Garg T, Baker LC, Mell MW. Postoperative surveillance and long-term outcomes after endovascular aneurysm repair among Medicare beneficiaries. JAMA Surg 2015;150:957-63. Kaladji A, Steinmetz E, Goueffic Y, Bartoli M, Cardon A. Longterm results of large stent grafts to treat abdominal aortic aneurysms. Ann Vasc Surg 2015;29:1416-25. Zarins CK, Crabtree T, Bloch DA, Arko FR, Ouriel K, White RA. Endovascular aneurysm repair at 5 years: does aneurysm diameter predict outcome? J Vasc Surg 2006;44:920-9; discussion: 929-31. Antonello M, Menegolo M, Piazza M, Bonfante L, Grego F, Frigatti P. Outcomes of endovascular aneurysm repair on renal function compared with open repair. J Vasc Surg 2013;58:886-93. Bartoli MA, Thevenin B, Sarlon G, Giorgi R, Albertini JN, Lerussi G, et al. Secondary procedures after infrarenal abdominal aortic aneurysms endovascular repair with second-generation endografts. Ann Vasc Surg 2012;26: 166-74. Beckerman WE, Tadros RO, Faries PL, Torres M, Wengerter SP, Vouyouka AG, et al. No major difference in outcomes for endovascular aneurysm repair stent grafts placed outside of instructions for use. J Vasc Surg 2016;64: 63-74.e2. Bisdas T, Weiss K, Eisenack M, Austermann M, Torsello G, Donas KP. Durability of the Endurant stent graft in patients undergoing endovascular abdominal aortic aneurysm repair. J Vasc Surg 2014;60:1125-31. Chang DC, Parina RP, Wilson SE. Survival after endovascular vs open aortic aneurysm repairs. JAMA Surg 2015;150:1160-6. Coppi G, Silingardi R, Saitta G, Gennai S. Single-center experience with the talent LPS endograft in patients with at least 5 years of follow-up. J Endovasc Ther 2008;15:23-32. EVAR trial participants. Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomised controlled trial. Lancet 2005;365:2187-92. Hobo R, Kievit J, Leurs LJ, Buth J. Influence of severe infrarenal aortic neck angulation on complications at the proximal neck following endovascular AAA repair: a EUROSTAR study. J Endovasc Ther 2007;14:1-11. Huang Y, Gloviczki P, Oderich GS, Duncan AA, Kalra M, Fleming MD, et al. Outcome after open and endovascular repairs of abdominal aortic aneurysms in matched cohorts using propensity score modeling. J Vasc Surg 2015;62:304-11.e2. Kim JH, Cho YK, Seo TS, Song MG, Jeon YS, Han YM, et al. Clinical outcomes for endovascular repair of abdominal aortic aneurysm with the Seal stent graft. J Vasc Surg 2016;64:1270-7. Lee K, Tang E, Dubois L, Power AH, DeRose G, Forbes TL. Durability and survival are similar after elective endovascular
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and open repair of abdominal aortic aneurysms in younger patients. J Vasc Surg 2015;61:636-41. Malas MB, Hicks CW, Jordan WD Jr, Hodgson KJ, Mills JL Sr, Makaroun MS, et al. Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks. J Vasc Surg 2017;65:1598-607. Mestres G, Zarka ZA, Garcia-Madrid C, Riambau V. Early abdominal aortic endografts: a decade follow-up results. Eur J Vasc Endovasc Surg 2010;40:722-8. Piffaretti G, Mariscalco G, Riva F, Fontana F, Carrafiello G, Castelli P. Abdominal aortic aneurysm repair: long-term follow-up of endovascular versus open repair. Arch Med Sci 2014;10:273-82. van Herwaarden JA, van de Pavoordt ED, Waasdorp EJ, Vos JA, Overtoom TT, Kelder JC, et al. Long-term singlecenter results with AneuRx endografts for endovascular abdominal aortic aneurysm repair. J Endovasc Ther 2007;14: 307-17. Verzini F, Romano L, Parlani G, Isernia G, Simonte G, Loschi D, et al. Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft. J Vasc Surg 2017;65:318-29. Yamamoto K, Komori K, Banno H, Narita H, Kodama A, Sugimoto M. Validation of patient selection for endovascular aneurysm repair or open repair of abdominal aortic aneurysm: single-center study. Circ J 2015;79: 1699-705. Chaikof EL, Brewster DC, Dalman RL, Makaroun MS, Illig KA, Sicard GA, et al. SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: executive summary. J Vasc Surg 2009;50:880-96. Moll FL, Powell JT, Fraedrich G, Verzini F, Haulon S, Waltham M, et al. Management of abdominal aortic aneurysms clinical practice guidelines of the European Society for Vascular Surgery. Eur J Vasc Endovasc Surg 2011;41:S1-58. Walker TG, Kalva SP, Yeddula K, Wicky S, Kundu S, Drescher P, et al. Clinical practice guidelines for endovascular abdominal aortic aneurysm repair: written by the Standards of Practice Committee for the Society of Interventional Radiology and endorsed by the Cardiovascular and Interventional Radiological Society of Europe and the Canadian Interventional Radiology Association. J Vasc Interv Radiol 2010;21:1632-55. Anderson JL, Halperin JL, Albert N, Bozkurt B, Brindis RG, Curtis LH, et al. Management of Patients With Peripheral Artery Disease (Compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;61:1555-70.
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59. Schanzer A, Messina LM, Ghosh K, Simons JP, Robinson WP, Aiello FA, et al. Follow-up compliance after endovascular abdominal aortic aneurysm repair in Medicare beneficiaries. J Vasc Surg 2015;61:16-22.e1. 60. Garg T, Baker LC, Mell MW. Adherence to postoperative surveillance guidelines after endovascular aortic aneurysm repair among Medicare beneficiaries. J Vasc Surg 2015;61: 23-7. 61. Kret MR, Azarbal AF, Mitchell EL, Liem TK, Landry GJ, Moneta GL. Compliance with long-term surveillance recommendations following endovascular aneurysm repair or type B aortic dissection. J Vasc Surg 2013;58:25-31. 62. Varabyova Y, Blankart CR, Schreyogg J. The role of learning in health technology assessments: an empirical assessment of endovascular aneurysm repairs in German hospitals. Health Econ 2017;26(Suppl 1):93-108. 63. Moise MA, Woo EY, Velazquez OC, Fairman RM, Golden MA, Mitchell ME, et al. Barriers to endovascular aortic aneurysm repair: past experience and implications for future device development. Vasc Endovascular Surg 2006;40:197-203. 64. Kicska G, Litt H. Preprocedural planning for endovascular stent-graft placement. Semin Intervent Radiol 2009;26: 44-55. 65. Rolls AE, Riga CV, Rudarakanchana N, Lee SL, Albayati M, Hamady M, et al. Planning for EVAR: the role of modern software. J Cardiovasc Surg (Torino) 2014;55:1-7. 66. Saratzis A, Calderbank T, Sidloff D, Bown MJ, Davies RS. Role of simulation in endovascular aneurysm repair (EVAR) training: a preliminary study. Eur J Vasc Endovasc Surg 2017;53:193-8. 67. Hoshina K, Ishimaru S, Sasabuchi Y, Yasunaga H, Komori K; Japan Committee for Stentgraft Management. Outcomes of endovascular repair for abdominal aortic aneurysms: a nationwide survey in Japan. Ann Surg 2019;269:564-73. 68. Columbo JA, Gladders BH, Wanken ZJ, Trooboff SW, Suckow BD, Stone DH, et al. IP027. Reimbursement for reintervention after endovascular aneurysm repair in the Vascular Quality Initiative. J Vasc Surg 2019;69:e117-8. 69. Sajid MS, Tai NR, Iftikhar M, Platts A, Baker DM, Hamilton G. Single-center experience of endovascular abdominal aortic aneurysm repair (EVAR) in patients not participating in the U.K. EVAR trials. Vasc Endovascular Surg 2007;41:383-8. 70. Rothenberg KA, Harris JC, Prentice HA, Hsu JH, Rehring TF, Nelken NA, et al. Risk of reintervention with Endologix AFX endovascular abdominal aortic aneurysm systems in an integrated health care system. J Am Coll Surg 2019;229:S334.
Submitted Oct 25, 2019; accepted Feb 3, 2020.
A systematic review and meta-analysis of long-term reintervention after endovascular abdominal aortic aneurysm repair Zachary J. Wanken, MD, MS,a,b J. Aaron Barnes, MD,a Spencer W. Trooboff, MD, MBA,b Jesse A. Columbo, MD, MS,a Tarun K. Jella, MPH,b Daniel J. Kim, MPH,b Arian Khoshgowari, MPH,b Natalie B. V. Riblet, MD, MPH,b and Philip P. Goodney, MD, MS,a,b Lebanon and Hanover, NH
ABSTRACT Objective: Patients who undergo endovascular aneurysm repair (EVAR) often require reintervention after the index repair. The long-term rate of reintervention and how this has changed with newer device technology are poorly understood. Therefore, we performed a systematic review and meta-analysis of the available literature to determine longterm freedom from reintervention after EVAR and the change in reintervention rates over time. Methods: We performed a systematic review of MEDLINE, Embase, Cochrane Library, and ClinicalTrials.gov in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included randomized controlled trials and observational studies that documented the rate of reintervention after EVAR. We performed a metaanalysis of Kaplan-Meier freedom from reintervention at each year after EVAR. We used linear regression to evaluate change in reintervention rate over time with newer device technology. Results: We included a total of 30 studies (randomized trials, n ¼ 3; observational studies, n ¼ 27) comprising 32,126 patients in this review and meta-analysis. Studies ranged in the implantation date of the EVAR device from 1996 to 2014. The probability of freedom from reintervention was 81% (95% confidence interval [CI], 77%-85%) at 5 years, 70% (95% CI, 65%76%) at 10 years, and 64% (95% CI, 46%-79%) at 14 years. Linear regression demonstrated an improvement in freedom from reintervention when results were stratified by the year of device implantation. At 1 year, estimated freedom from reintervention improved from 90% in 1998 to 94% in 2008 (n ¼ 26 studies; R2 ¼ 0.11; P ¼ .10). At three years, estimated freedom from reintervention improved from 77% in 1998 to 90% in 2008 (n ¼ 26 studies; R2 ¼ 0.27; P ¼ .006). At 5 years, estimated freedom from reintervention improved from 68% in 1998 to 81% in 2008 (n ¼ 22 studies; R2 ¼0.12; P ¼ .12). At 7 years, estimated freedom from reintervention improved from 51% in 1998 to 86% in 2011 (n ¼ 22 studies; R2 ¼ 0.40; P ¼ .015). Conclusions: EVAR patients remain at risk for reintervention indefinitely, and therefore lifelong surveillance is imperative. Encouragingly, reintervention rates have improved over time, with newer devices exhibiting lower rates. Reintervention rate remains an important metric for new devices and registries. (J Vasc Surg 2020;-:1-10.) Keywords: Abdominal aortic aneurysm; Endovascular aortic aneurysm repair; Reintervention
Abdominal aortic aneurysm (AAA) is a common disease, and rupture represents a life-threatening emergency with mortality approaching 90%.1,2 In the United States, ruptured AAA is the fourteenth leading cause of death.3 Major open surgery was traditionally required for repair.4 Since the early 2000s, however, there has been a major paradigm shift to endovascular aneurysm repair (EVAR).5 Now, nearly 80% of patients who are treated surgically for AAA will undergo EVAR. EVAR is associated with lower in-hospital morbidity and
mortality and a shorter hospital stay compared with traditional open surgical repair.6,7 The tradeoff between EVAR and open surgical repair is durability. In the 3 years after EVAR, up to one-fifth of patients require a reintervention procedure.7-10 Reinterventions include any secondary surgical or endovascular procedure pertaining to the EVAR device or AAA and may consist of minor catheter-based procedures as well as major surgical revision operations.7,10,11 Whereas many prior studies have documented reintervention
From the Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center,
Correspondence: Zachary J. Wanken, MD, MS, Section of Vascular Surgery, 3V,
Lebanona; and The Dartmouth Institute for Health Policy and Clinical Prac-
Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH
tice, Hanover.b
03766 (e-mail: [email protected]).
P.P.G. is supported by a grant from the American Heart Association, and Z.J.W.
The editors and reviewers of this article have no relevant financial relationships to
and J.A.B. are supported as research fellows under this grant. This publication
disclose per the JVS policy that requires reviewers to decline review of any
is the result of coursework completed through the support of this education
manuscript for which they may have a conflict of interest.
grant. The American Heart Association did not have any direct role in the
0741-5214
study or publication.
Published by Elsevier Inc. on behalf of the Society for Vascular Surgery.
Author conflict of interest: none.
https://doi.org/10.1016/j.jvs.2020.02.030
Presented in the poster competition at the 2019 Vascular Annual Meeting of the Society for Vascular Surgery, National Harbor, Md, June 12-15, 2019.
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procedures to be common after EVAR, changes in reintervention rates over time are less well described. Therefore, our understanding of reintervention in relation to progression of device technology and surgical technique is limited. Our objective was to use the available literature to document the long-term rate of reintervention after EVAR and to determine change in reintervention rate over time. To accomplish this, we completed a systematic review and meta-analysis characterizing reintervention after EVAR for infrarenal AAA. Patients, providers, and payers all stand to benefit from improved understanding of the long-term complication profile of EVAR.
METHODS Inclusion and exclusion criteria. Before conducting this review, we devised a protocol outlining our planned approach to the identification and selection of studies. In doing this, we adhered to standard methodology for the analysis outlined by the Cochrane Handbook and followed recommended guidelines from the Preferred Reporting Items for Systematic Reviews and MetaAnalyses statement.12,13 The original protocol and record of all protocol changes are available from the authors on request. We used the following inclusion criteria to determine study eligibility: randomized controlled trials or observational studies (study design) evaluating Kaplan-Meier freedom from reintervention procedure in patients who have undergone EVAR for infrarenal AAA with an average (reported mean or median) of 36 months of follow-up or more and published in the English language. Studies were excluded if they solely or disproportionately evaluated patients with ruptured AAA or anatomy outside of instructions for use. Studies focusing on patients with collagen vascular disorders, mycotic AAA, and inflammatory AAA were also excluded. Patients with complex branched and fenestrated repairs or chimney and snorkel grafting were excluded. Databases and search terms. We searched MEDLINE (inception-October 2018), Embase (inception-October 2018), Cochrane Library (inception-October 2018), and ClinicalTrials.gov (inception-October 2018) to identify published articles relevant to our research question. We used exploded Medical Subject Headings terms and keywords for the themes of aortic aneurysm and endovascular procedures. We combined these themes using the Boolean terms “AND” and “OR” as appropriate. We did not apply limits to our initial search but later excluded studies during abstract review that could not be obtained in the English language. Study selection. We compiled studies from each database search and removed duplicates using EndNote software (Clarivate Analytics, Philadelphia, Pa). We
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ARTICLE HIGHLIGHTS d
d
d
Type of Research: Systematic review and metaanalysis of published rates of reintervention procedures after endovascular aneurysm repair (EVAR) Key Findings: Up to 19% of EVAR patients will require a reintervention at 5 years, 30% at 10 years, and 35% at 14 years. However, reintervention rates have improved over time. Through 7 years of follow-up, the proportion of patients who do not require reintervention has improved from 50% in 1998 to 86% in 2008. Take Home Message: EVAR patients remain at risk for reintervention indefinitely. However, reintervention rates have improved over time, with newer devices exhibiting lower rates.
transitioned the resultant list of studies to Rayyan QCRI software (Qatar Computing Research Institute, Doha, Qatar) for title and abstract review.14 We next reviewed the full-text manuscripts of studies that passed title and abstract review. Each full-text manuscript was reviewed by at least two authors to determine final study eligibility. If there was disagreement on inclusion, a third author reviewed the manuscript to make the final inclusion decision. Our review process yielded several manuscripts that used overlapping data. For randomized controlled trials, we used the most recent for data collection and analysis, and we used earlier reports to determine inclusion eligibility or to gather demographic information as needed. For example, we identified multiple manuscripts for the EVAR 1 and Dutch Randomized Endovascular Aneurysm Management (DREAM) trials.15-23 For observational studies, we included the studies with the greatest number of patients or longest follow-up period for analysis. To assess methodologic quality, we used the Cochrane risk of bias tool for randomized controlled trials and the modified Newcastle-Ottawa Scale for nonrandomized studies.24,25 Outcome measures and data collection. Our primary outcome measure, freedom from reintervention procedure, was determined from published Kaplan-Meier tables or curves. Reintervention was categorized as any surgical or endovascular procedure occurring after the index operation and pertaining to the EVAR procedure. Reintervention procedures included minor catheter-based procedures as well as major surgical revisions.7,10,11 We categorized major reinterventions as those that required laparotomy or axillofemoral bypass or were performed for ruptured AAA. One study categorized reinterventions as “life-threatening,” and these were included in the major reintervention group.9 We extracted study data using a standardized data collection form. Data
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Fig 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram of study inclusion. K-M, Kaplan-Meier.
extraction was performed independently by at least two authors and cross-checked for accuracy. A third author reviewed discordant data as needed to ensure accuracy. For studies without a published life table, we used DigitizeIt software (I. Bormann, Braunschweig, Germany) to estimate the yearly Kaplan-Meier value directly from the published figure.26 Data synthesis. In our first analysis, we compiled Kaplan-Meier freedom from reintervention on a yearly basis after EVAR procedures. To report this, we performed a meta-analysis for each year using the metaprop command in Stata (StataCorp LP, College Station, Tex). For each year, studies were included if they reported the number of patients at risk for that year, and studies were excluded if they did not report the number of patients at risk. Six studies did not report the number of patients at risk for any time period and were excluded from analysis.27-32 For our secondary analysis, we used linear regression to examine the association between Kaplan-Meier freedom from reintervention and median year of EVAR implantation. We performed this analysis to evaluate the effect of improved devices, imaging, and technique on the need for reintervention procedures. We specifically examined snapshots of freedom from reintervention at 1 year, 3 years, 5 years, and 7 years after index EVAR. Two studies stratified analysis by urgency of repair.33,34 For these studies, we used the data from the group with elective repair and excluded the estimates for patients with urgent or emergent repair. We excluded studies that provided stratified outcomes for
other subgroup types.32,35-37 We similarly used linear regression to evaluate the change in proportion of major reinterventions over time.
RESULTS Search results and studies included for analysis. Our search yielded 4946 studies from MEDLINE, 2916 studies from Embase, 123 studies from Cochrane Library, and 91 studies from ClinicalTrials.gov. A total of 1152 studies were duplicated between these search methods and removed. An additional 6690 studies were removed through title and abstract review, and 234 studies were subjected to full-text review. We included a total of 30 studies in the final review.10,23,27-54 Our selection process is shown in our Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram (Fig 1). Table I outlines the study characteristics of our 30 included studies, which consisted of three randomized controlled trials and 27 observational studies. Studies are included from 11 countries spanning North America, Europe, and Asia. A total of 32,126 patients were included in our analysis with a range of 50 to 12,239 patients per individual study. The patients were predominantly elderly and male. Range of mean aneurysm size was 53 to 70 mm. Methodologic quality of included studies. Overall, the methodologic quality of our included studies was good, and reporting of outcomes was homogeneous (Table II). The definition of reintervention was remarkably similar across all studies. Attrition and censoring were considerable across all studies. However, there were
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Table I. Studies included in systematic review and meta-analysis Country
Procedural year range
No. of EVAR patients
Italy
2003-2007
160
72.3
150 (93.8)
France
1998-2008
162
74.7
157 (96.9)
57.1
United States
2003-2014
176
75.3 6 8.7
144 (81.8)
N/A
Bisdas, 2014
Germany
2007-2010
273
73 6 9
246 (90)
N/A
Broos, 2016
The Netherlands
1998-2012
Study Antonello, 2013 Bartoli, 2012 Beckerman, 2016
Chang, 2015
United States
2001-2009
Coppi, 2008
Italy
1997-2001
Deery, 2018 EVAR trial participants, 2005 Garg, 2015
Hammond, 2016
Age, years
Male
Aneurysm diameter, mm 61 6 5
773 (elective)
72.2 6 7.7
697 (90.2)
59 6 12
90 (ruptured)
73.4 6 8.5
73 (81.1)
70 6 18
12,239
75.1
50
10,384 (84.4)
N/A
72
49 (98)
58
United States
2011-2012
178
71
146 (82)
54.5
United Kingdom
1999-2003
166
76.8 6 6.2
141 (85)
64
United States
2002-2005
3944 (incomplete surveillance)
76.2 6 6.2
3324 (84.3)
N/A
3944 (complete surveillance)
76.4 6 6.3
3274 (83.0)
N/A
United Kingdom
Hobo, 2007
The Netherlands and Italy
Huang, 2015
United States
Kaladji, 2015
France
2007-2013 1996-2006 2000-2011 1998-2012
234
N/A
208 (88.9)
N/A
4031
72.1 6 7.7
3820 (94.8)
57.9 6 10.4
74 6 7.1
497 (86)
57 6 10
738 (endograft diameter <32 mm)
74.8 6 8.3
687 (93.1)
56.1 6 10.1
170 (endograft diameter >32 mm)
76 6 8.3
164 (96.5)
58 6 10.1
558
Kim, 2016
Korea
2007-2010
126
71 6 8
105 (83)
61 6 13
Lee, 2015
Canada
2000-2013
50
57.1
46 (92)
56.4
Makaroun, 2002
United States
1995-1998
242
N/A
N/A
Malas, 2017
United States
2006-2011
67
74.0 6 7.9
Mestres, 2010
Spain
1997-2000
Nagpal, 2007
Canada
1997-2001
61
Oranen, 2006
The Netherlands
1998-2005
56
Patel, 2018
United Kingdom
1999-2004
626
100
52 (77.6)
N/A 54.3 6 9.0
71.6
58 (95.1)
60.8
73 6 7.7
84 (84)
62 6 6.6
73 6 9
51 (91)
70.1 6 15.9
74.1 6 6.1
565 (90)
65 6 9 50
Italy
2000-2005
138
71.5 6 8.6
125 (91)
Vaaramaki, 2007
Finland
1997-1999
48
70
44 (92)
57
van Herwaarden, 2007
The Netherlands
1996-2003
212
71.3 6 7
197 (93)
59.1 6 10.6
van Schaik, 2017
Piffaretti, 2014
The Netherlands
2000-2003
173
70.7 6 6.6
161 (93)
60.6 6 9.0
Verzini, 2017
Italy
2000-2011
805
73.3 6 7.7
805 (91.3)
55.3
Wang, 2009
United States
N/A
100 (small AAA)
72.4 6 6.7
88 (88)
N/A
Japan
2007-2014
United States
1998-1999
Yamamoto, 2015 Zarins, 2006
87 (large AAA)
73.9 6 7.4
78 (90)
N/A
426
77.9 6 6.2
354 (83.1)
53.2 6 1.5
145 (small AAA)
71.3 6 7.1
131 (90)
N/A
461 (medium AAA)
73.4 6 7.6
406 (88)
N/A
317 (large AAA)
74.6 6 8.6
279 (88)
N/A
AAA, Abdominal aortic aneurysm; EVAR, endovascular aneurysm repair; N/A, not available. Categorical variables are presented as number (%). Continuous variables are presented as mean 6 standard deviation.
some important differences in cohort demographics between studies. Over time, the comorbidity burden of patients declined as EVAR became available to more
patients. Two studies35,42 relied on administrative claims data, which contrasted with trial, registry, or chart review data in our other included studies.
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Table II. Methodologic quality of included studies using the modified Newcastle-Ottawa Scale for nonrandomized studies and Cochrane risk of bias tool for randomized controlled trials Modified Newcastle-Ottawa Scale Individual assessment domains
Cohort studies
Representative cohort
Ascertainment of exposure
Assessment of outcomes
Length of follow-up
Completeness of follow-up
Overall risk of bias judgment
Antonello, 2013
Low
Low
Low
Low
Moderate
Low
Moderate
Low
Low
Low
Moderate
Low
Beckerman, 2016
Low
Low
Low
Low
Moderate
Low
Bisdas, 2014
Low
Low
Low
Low
Moderate
Low
Broos, 2016
Moderate
Low
Low
Low
Moderate
Low
Chang, 2015
Moderate
Low
Low
Low
Moderate
Low
Bartoli, 2012
Coppi, 2008
Low
Low
Low
Low
Moderate
Low
Deery, 2018
Moderate
Low
Low
Low
Moderate
Low
Garg, 2015
Low
Low
Low
Low
Moderate
Low
Hammond, 2016
Low
Low
Low
Low
Moderate
Low
Hobo, 2007
Low
Low
Low
Low
Moderate
Low
Huang, 2015
Moderate
Low
Low
Low
Moderate
Low
Kaladji, 2015
Moderate
Low
Low
Low
Moderate
Low
Kim, 2016
Moderate
Low
Low
Low
Moderate
Low
Lee, 2015
Moderate
Low
Low
Low
Moderate
Low
Makaroun, 2002
Low
Moderate
Low
Low
Low
Moderate
Malas, 2017
Low
Low
Low
Low
Moderate
Low
Mestres, 2010
Low
Low
Low
Low
Moderate
Low
Nagpal, 2007
Moderate
Low
Low
Low
Moderate
Low
Oranen, 2006
Low
Low
Low
Low
Moderate
Low
Piffaretti, 2014
Moderate
Low
Low
Low
Moderate
Low
Vaaramaki, 2007
Low
Low
Low
Low
Moderate
Low
van Herwaarden, 2007
Low
Low
Low
Low
Moderate
Low
Verzini, 2017
Low
Low
Low
Low
Moderate
Low
Wang, 2009
Low
Low
Low
Low
Moderate
Low
Yamamoto, 2015
Low
Low
Low
Low
Moderate
Low
Zarins, 2006
Low
Low
Low
Low
Moderate
Low
Cochrane risk of bias tool Individual assessment domains Randomized controlled trials
Random sequence generation
Allocation concealment
Blinding (participants and personnel)
Blinding (outcome assessment)
Incomplete outcome data
Selective reporting
Other bias sources
Overall risk of bias judgment
EVAR trial participants, 2005
Low
Low
High
Moderate
Low
Low
Low
Low
Patel, 2018
Moderate
Low
High
Moderate
Low
Low
Low
Low
van Schaik, 2017
Low
Low
High
Moderate
Low
Low
Low
Low
Meta-analysis of Kaplan-Meier freedom from reintervention. Fig 2 demonstrates long-term Kaplan-Meier freedom from reintervention as determined by our meta-analysis of yearly estimates. The probability of freedom from reintervention was 81% (95% confidence
interval [CI], 77%-85%) at 5 years (patients contributing to estimate, 4405; studies contributing to estimate, 16), with a range of 23% to 99% across studies. At 10 years, the probability of freedom from reintervention was 70% (95% CI, 65%-76%; patients, 364; studies, 8), with a range
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Fig 2. Compilation meta-analysis of Kaplan-Meier freedom from reintervention after endovascular aneurysm repair (EVR). Each yearly estimate is composed of all studies meeting inclusion criteria and reporting the number of patients at risk at that time point.
of 19% to 98% across studies. At 14 years, the probability of freedom from reintervention was 64% (95% CI, 46%79%; patients, 28; studies, 1). Linear regression of study year and freedom from reintervention. Fig 3 demonstrates linear regression of study year and freedom from reintervention. During the years of our included studies, we found improvement in freedom from reintervention at 1 year, 3 years, 5 years, and 7 years after index EVAR. At 1 year, estimated freedom from reintervention improved from 90% in 1998 to 94% in 2008 (n ¼ 26 studies; R2 ¼ 0.11; P ¼ .10). At 3 years, estimated freedom from reintervention improved from 77% in 1998 to 90% in 2008 (n ¼ 26 studies; R2 ¼ 0.27; P ¼ .006). At 5 years, estimated freedom from reintervention improved from 68% in 1998 to 81% in 2008 (n ¼ 22 studies; R2 ¼ 0.12; P ¼ .12). At 7 years, estimated freedom from reintervention improved from 51% in 1998 to 86% in 2011 (n ¼ 22 studies; R2 ¼ 0.40; P ¼ .015). Breakdown of reintervention types. A total of 18 studies provided granular data for evaluation of the types of reintervention that were required. The total number of reinterventions reported in these studies ranged from 6 to 124. The proportion of major reinterventions reported across these studies ranged from 0% to 62.5%. We found no significant relationship between the year of device implantation and proportion of major reintervention (Fig 4). Catheter-based reinterventions were much more common overall and ranged from 14.6% to 93.8% across the included studies.
DISCUSSION Endovascular repair of aortic aneurysms surged in popularity because of drastic improvements in shortterm morbidity and mortality. Concerns about durability of repair developed during a longer period as studies published long-term follow-up. In this systematic review and meta-analysis of the published literature, we found that EVAR patients remain at risk of reintervention indefinitely after the index operation. Through 14 years of available follow-up, our results demonstrate that patients are at persistent risk of reintervention. More than one-third of EVAR patients required a secondary procedure during follow-up. We encouragingly found, however, that fewer patients now require reintervention as technology and surgical technique have improved over time. For example, the cumulative number of patients requiring reintervention within 7 years of index EVAR has been cut in half. Our results support the current guidelines of the Society for Vascular Surgery, European Society for Vascular Surgery, U.S. Food and Drug Administration, American College of Cardiology, American Heart Association, and Society of Interventional Radiology, which recommend indefinite imaging and clinical follow-up after EVAR.55-58 There is simply no safe time to stop surveillance imaging in the healthy patient. Unfortunately, more than half of EVAR patients experience a lapse in follow-up surveillance within 5 years of repair.59-61 Thorough preoperative discussion is critical to identify patients’ preferences regarding tradeoffs in short-term complications for long-term durability. Patients who value durability or
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Fig 3. Linear regression demonstrating the association of median study year and freedom from reintervention at four different time points: 1 year, 3 years, 5 years, and 7 years after the index repair. EVR, Endovascular aneurysm repair.
Fig 4. Linear regression demonstrating the association of median study year and proportion of reinterventions classified as major. EVR, Endovascular aneurysm repair.
prefer not to return for follow-up appointments may benefit from open surgical repair rather than EVAR. Patients with significant comorbidity burden should also be chosen carefully for EVAR as many of these patients will require multiple operations and therefore repeated risk of anesthesia and operative stress. Despite current concerns and considerations for patients in need of AAA repair, we are encouraged by the improvement in durability seen over time and believe there are several contributing factors. As with any new
procedure, surgeons experienced an initial learning curve to become facile with EVAR technology and its limitations.62 Second, device technology has improved through advances in endograft engineering and design.63 Third, case planning and execution have benefited from advances in imaging modalities, especially three-dimensional reconstructive software and hybrid operating rooms with fixed imaging systems.64,65 Modern surgeons have the capability to fully plan and to execute the case in virtual reality before even seeing the patient.66 It is difficult to predict which technologic advances might decrease the need for reintervention even further. Current device design, imaging, and surgeon skill, however, have pushed endovascular aortic repair beyond the infrarenal segment to include complex repairs of thoracoabdominal and arch aneurysms. In light of our findings, we encourage surgeons to focus on improving several specific aspects of aortic aneurysm care. For day-to-day clinical care, we recommend frank discussion to determine the patient’s preferences, weighing short-term benefits against long-term durability, which will help guide consideration of surgical AAA repair method. We recommend that device trials and registries maintain reintervention as an important metric for evaluation. A study by Hoshina et al67 illustrated the benefit of maintaining a robust registry, which allowed them to evaluate AAA repair outcomes in
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>38,000 patients throughout the country of Japan. Costeffectiveness is another important metric that stakeholders must continue to track. Reinterventions have been shown to cost the health care system an amount equivalent to the initial EVAR operation.68 Further improvements in reintervention rate would continue to improve the overall cost-effectiveness of EVAR compared with open surgical repair. Long term, we believe that ongoing collaboration between surgeons, engineers, and imaging specialists is critical and will further improve EVAR technology for broadened applications throughout aortic aneurysm care. We acknowledge limitations of our study. Our review was limited to the available literature and is susceptible to publication bias. Comorbidity burden of the patients included changed during the course of our study. Studies published in the early years of EVAR are composed of patients with higher comorbidity burden compared with later studies because EVAR was initially available primarily for use in patients physiologically unfit for traditional open repair.69 It is difficult to know how the improving health of EVAR patients over time may contribute to reintervention rates over time. We were also unable to evaluate outcomes for individual graft configurations. For example, the “build up” configuration used with the Endologix AFX (Endologix, Irvine, Calif) has been associated with high rates of type III endoleak and reintervention.70 Because of the heterogeneity of device use across studies, including many devices that are no longer on the market, we were unable to evaluate the individual effect of device construction. Last, we used studies that reported Kaplan-Meier freedom from reintervention and were unable to include studies that reported reintervention as a combined end point or did not include a Kaplan-Meier analysis.
CONCLUSIONS Patients who undergo EVAR remain at risk for reintervention indefinitely. For healthy patients, there is no safe time to be discharged from follow-up, and surveillance imaging should be continued indefinitely. Encouragingly, reintervention rates have improved over time with advances in device technology, aortic imaging, and surgical technique. Reintervention procedures remain an important benchmark in endograft device design and should remain an important focus of device trials and registries.
AUTHOR CONTRIBUTIONS Conception and design: ZW, ST, JC, TJ, DK, AK, NR, PG Analysis and interpretation: ZW, JB, ST, JC, TJ, DK, AK, NR, PG Data collection: ZW, JB, TJ, DK, AK Writing the article: ZW, TJ, DK, AK Critical revision of the article: ZW, JB, ST, JC, TJ, DK, AK, NR, PG
2020
Final approval of the article: ZW, JB, ST, JC, TJ, DK, AK, NR, PG Statistical analysis: ZW, ST Obtained funding: Not applicable Overall responsibility: ZW
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Submitted Oct 25, 2019; accepted Feb 3, 2020.