University of Groningen
New measures to prevent inguinal infections in vascular surgery
Vierhout, Bastiaan Pieter
DOI:
10.33612/diss.97720548
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Publication date: 2019
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Vierhout, B. P. (2019). New measures to prevent inguinal infections in vascular surgery. Rijksuniversiteit Groningen. https://doi.org/10.33612/diss.97720548
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Chapter 4
Arteriotomy closure devices in EVAR, TEVAR, and TAVR:
A systematic review and meta-analysis of randomized
clinical trials and cohort studies
Bastiaan P. Vierhout MD1, Robert A. Pol MD, PhD2, Mostafa El Moumni MD, PhD,
MSCE2, Clark J. Zeebregts MD, PhD3
1. Department of Surgery, Wilhelmina Ziekenhuis, Assen, The Netherlands
2. Department of Surgery, University Medical Center Groningen, University
of Groningen, Groningen, The Netherlands
3. Department of Surgery, Division of Vascular Surgery, University Medical
Center Groningen, University of Groningen, Groningen, The Netherlands
Abstract
Objectives: Cardiac and vascular surgery benefit from percutaneous interventions.
Arteriotomy closure devices (ACD’s) enable minimal invasive access to the common femoral artery (CFA). The objective of this review was to assess the differences between ACDs and surgical cut down (SCD) of the CFA regarding the number of complications, duration of surgery (DOS), and hospital length of stay (HLOS).
Design: A systematic literature search with predefined search terms was performed
using MEDLINE, Embase, and the Cochrane Library (2000-2016). All studies reporting on ACD and SCD for a puncture of the CFA of at least 12 French (Fr.) were assessed for eligibility.
Methods: Included were randomized controlled trials and cohort studies comparing
both techniques. Patient characteristics, exclusion criteria, and conversion rates were evaluated. Complications, DOS, and HLOS were compared.
Materials: A total of 17 studies were included, describing 7889 vascular access
sites; four studies were ran-domized trials, two studies reported form a prospective database, and 11 studies reported retrospective cohorts.
Results: ACD was associated with fewer post-operative seromas (odds ratio [OR]
0.15, 95% confidence interval [CI] 0.06-0.35), wound dehiscence (OR 0.14, 95% CI 0.03-0.78) and surgical site infections (OR 0.38, 95% CI 0.23-0.63).
Postoperative pseudoaneurysms were significantly more common in the ACD group (OR 3.83, 95% CI 1.55-9.44). In five of 17 studies, DOS and HLOS were not reduced in the ACD group. When all studies reporting a mean DOS and/or HLOS were compared in a non-parametric analysis, neither was significantly different.
Conclusion: This meta-analysis favours ACD regarding the number of wound
complications compared with SCD in endovascular aneurysm repair, thoracic endovascular aneurysm repair, and transcatheter aortic valve repair. Treatment duration (DOS and HLOS) was not reduced in ACD. The differences are of limited clinical significance and with this equivocal quality of evidence, the ACD may be considered safe for CFA access in suitable patients.
Introduction
Initially, access for endovascular aneurysm repair (EVAR), thoracic
endovascular aneurysm repair (TEVAR), and transcatheter aortic valve repair (TAVR) was achieved by surgical cut down (SCD) of one or both groins, then arteriotomy closure devices (ACD) emerged as an alternative to SCD in all of these procedures. ACDs have the potential to reduce the length of the incision, the
duration of surgery (DOS), the risk of wound com-plications, and the hospital length of stay (HLOS), and thereby improve patient satisfaction (1-5). Early studies
mentioned a long learning curve (6-8) and many exclusion criteria, such as calcified arteries and morbid obesity. SCD equally remains a challenge in these patients. A meta-analysis comparing ACD and SCD, published in 2011, only described a relation between sheath-size and the necessity for conversion but did not evaluate complication rate or duration of treatment (9). Therefore, the available literature on patients treated for an aneurysm of the abdominal or thoracic aorta or percutaneous aortic valve implantation with either the use of an ACD or SCD was investigated. A comparison between ACD and SCD was made in terms of effectiveness and applicability, complications and duration of treatment in patients selected for an endovascular procedure. A systematic review was performed and a meta-analysis of the available data is presented.
Materials and Methods
This study was carried out following the recommendations of the Cochrane Collaboration and according to the “Preferred Reporting Items for Systematic reviews and Meta-Analysis” (PRISMA)-guideline to ensure the quality and completeness for both systematic review and meta-analysis (10-12).
The search included the period January 2000–August 2016. Articles that specifically examined the differences between ACD and SCD of femoral arterial access
measuring 12 French (Fr.) or more were searched for.
Information sources
A systematic literature search with a combination of medical subject heading (MeSH) terms and free text words was entered in MEDLINE. The terms
“percutaneous closure” or “percutaneous repair” or “percutaneous access” were combined with “aortic aneurysm*[MeSH] or aortic valve*[MeSH] or abdominal
aortic aneurysm* or thoracic aneurysm* or vascular*”. The Cochrane Library and Embase databases were searched with the terms: “percutaneous access”, “percutaneous closure”, and “percutaneous repair”, combined with “aortic
aneurysm”, “thoracic aneurysm”, “aortic valve”, and “surgical cut down”. In addition, a manual cross-reference search was performed of the identified literature.
Literature search
Two independent reviewers (B.P.V., R.A.P.) performed the literature search and assessed the relevance of each source for inclusion in the review. Disagreements were resolved by discussion and adjudicated by a third reviewer (C.J.Z.). Types of studies considered for a pooled analysis included randomized controlled trials (RCTs), and cohort studies that met the following criteria: (i) were published as full articles; (2) compared access related complications with ACD and SCD applied during EVAR, TAVR and TEVAR; and (3) were published in English.
Types of intervention
ACD was developed for remote arterial closure of arterial punctures measuring 12 Fr. or more. It was defined as a small incision of 1-2 cm and remote closure of the arterial puncture. SCD was defined as a longitudinal, transverse or oblique incision, visual access and puncture of the CFA, followed by arterial suture or fascia closure technique.
Study selection
To ascertain validity of the included articles regarding their selection process, design, analyses and outcome measures, the Newcastle-Ottawa Quality Assessment Scale (NOS) for cohort studies was used (13). Two investigators independently performed this assessment and disagreements were resolved by discussion and consensus (B.P.V., R.A.P.). The methodological quality and risk of bias were assessed following instructions of the Cochrane Handbook for Systematic Reviews of Interventions (14). The included studies were evaluat-ed on various domains. Attention was paid to random sequence generation, allocation
concealment, blinding of participants, personnel and outcome assessment, incomplete outcome data, selective outcome reporting and other bias.
Based on the aforementioned components, calculations were performed on all included studies. A separate analysis of the RCT’s was performed.
Data collection process
A standard data extraction form was completed for each article and converted to a predefined template with demographics, procedural data and rate of complications. Emphasis was given to the exclusion criteria for ACD use in the included studies and the size of the sheath used for implantation. The exclusion criteria were registered and reviewed. Possible relations between ACD sheath size and the conversion rate were explored.
Statistical analysis
The primary outcome measure was the effect of the different interventions (ACD versus SCD) on the occur-rence of complications: hematoma, seroma, femoral neuropathy, dehiscence of the wound, surgical site in-fection (SSI),
pseudoaneurysm formation, iliac rupture, and dissection/rupture/stenosis/fistula of the CFA. Odds ratios (OR) and 95% confidence intervals (95% CI) for each complication were calculated. The second-ary outcomes were DOS (minutes) and HLOS (days). For these continuous outcomes, the difference in means (and 95% CI) was the effect measure.
A meta-analysis was performed for each endpoint if at least two studies could be combined. The random effects model was used for computing a summary statistic in the meta-analyses using the package metaphor in R (15), because of the expected high heterogeneity between studies. The DerSimonian and Laird method was used to estimate the variance between studies. Statistical heterogeneity was assessed by visual inspection of the forest plots and by using the Q-statistic with p < .10
indicating significant heterogeneity. To assess potential publication bias, a funnel plot was constructed and examined visually for asymmetry (16).
For dichotomous data ORs were calculated with a 95% CI. In studies that did not mention data trial infor-mation was ignored. Quantitative analyses were confined to data provided by the authors with a SD (DOS and HLOS). When only the
inter-quartile range was provided, normal distribution was not guaranteed and SD was not calculated. In the absence of a SD for continuous data in the original articles, DOS and HLOS were compared using the Mann-Whitney U test.
Results
The systematic search resulted in 746 potentially eligible articles. After initial screen-ing of titles 227 articles were retrieved for abstract review. Of these abstracts a fur-ther 194 were excluded based on the inclusion criteria. After full manuscript reading a total of 17 articles were included in the analysis (Figure 1).
728 titles identified through database searching
19 additional records identified through other sources
746 titles after duplicates removed
746 titles screened
227 abstracts assessed for eligibility
33 full text articles assessed for eligibility
17 studies included in qualitative synthesis 17 studies included in quantitative synthesis
(meta-analysis)
519 titles not relevant
194 abstracts excluded: - 17 abstracts, no articles - 31 case reports
- 65 reports without comparison - 45 no femoral/percut. access - 21 reviews/protocols - 1 no complication mentioned - 1 no equal comparison - 3 concerning children - 9 insuff. sheath calibre - 1 article in Chinese 16 full text articles excluded: - 3 meta-analyses
- 4 reports without comparison - 8 no report of complications - 1 protocol Included Eligibility Scr eening Iden tific ation
Figure 1. Study flow chart (“Preferred Reporting Items for Systematic reviews and Meta-Analysis” diagram).
Included studies
Seventeen studies included a total of 7889 femoral artery accesses used for endo-vascular intervention (1-5, 8, 17-27). Six papers described a prospective design. Four of these were considered high-quality studies by the NOS classification (17, 18, 21, 24). These had a low risk of selection bias, due to randomization. Eleven others were retrospective studies. Blinding of outcome was absent in all studies, im-posing a performance and detection bias for the meta-analysis. Most studies were unclear about their completeness of reporting data (attrition bias). Reporting bias was absent or uncertain in most studies (Table 1).
Author Study type Selection
Compa-rability Outcome Random sequence generation Allocation concealment Blinding of participants/personnel Blinding of outcome assessment Incomplete outcome data Selective reporting Other bias
Larzon 2015 Nelson 2014 Holper 2014 Torsello 2003 Jean-B. 2008 Morasch 2004 Metcalfe 2013 Etezadi 2011 Ni ZH 2011 Bensley 2012 Kontopod.2015 Mousa 2013 Nakamura 2014 Rachel 2002 Buck 2015 Smith 2009 Prosp. randomized Prosp. randomized Prosp. randomized Prosp. randomized Prosp. cohort Retrosp. cohort Retrosp. cohort Retrosp. cohort Retrosp. cohort Retrosp. cohort Retrosp. cohort Retrosp. cohort Retrosp. cohort Retrosp. cohort Prosp. registry Retrosp. +B1:B17cohort *** *** *** *** ** ** ** ** ** ** *** ** ** ** ** ** ** ** ** ** * * * * * * -* * * -*** *** *** *** *** *** *** *** *** *** *** *** *** *** *** ***
Table 1. Evaluation of quality of included studies. NOS= New-castle–Ottawa Quality Assessment Scale;
RCT=randomized controlled trial; Prosp.= prospective; Retrosp.= retrospective. ***High quality; **reasonable quality;* low and very low quality; (+) demands of quality met; (–) demands of quality not met; (?) unknown.
Percutaneous access was not performed in emergency surgery in 11 studies and in 4 studies this information was absent. Calcified CFAs excluded percutaneous access in 8 studies. Other exclusion criteria were mentioned in five or less of the 17 included studies (<30%) and consisted of iliac kinking or stenosis, obesity, CFA scarring or diameter <7mm, CFA aneurysm, connective tissue disease, mono-iliac device, psychiatric disease, high CFA bifurcation, device >18 Fr. and pre-existing groin wounds (Table 2).
Author (year) Inclusion Exclusion
E V A R T E V A R T A V R rAAA Calcified CF A
Iliac kinking/stenosis Obesity CFA < 7mm Scarred CF
A
Combined surgery CFA aneurysm Connective tissue disease Monoiliac device Psychiatry COOK, Medtronic, Guidant Ancure High CF
A bifurcation
Device > 18 french Groin wounds
Larzon (2015) Nelson (2014) Holper (2014) Torsello (2003) Jean-B. (2008) Morasch (2004) Metcalfe (2013) Spitzer (2016) Etezadi (2011) Ni ZH (2011) Bensley (2012) Kontopodis (2015) Mousa (2013) Nakamura (2014) Rachel (2002) Buck (2015) Smith (2009) x x x x x x x x x x x x x x x x x x x x x x x x x x x ? ? x ? ? x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x 13 4 2 11 8 5 4 4 3 3 2 2 2 1 1 1 1 1
Table 2. Inclusion and exclusion criteria in the various studies. Calcified common femoral arteries
(CFAs), obesity, and kinked iliac arteries are exclusion criteria that were mentioned most often. EVAR= endovascular aneurysm repair; TEVAR= thoracic endovascular aneurysm repair; TAVR= transcatheter aortic valve repair; rAAA= rupture of an aneu-rysm of the abdominal aorta; X= mentioned as exclusion criteria; ?= not mentioned.
Intervention
Ten studies assessed the use of an ACD in EVAR (2-4, 18-20, 22, 24-26), one in TEVAR (23), and three in TAVR (5, 21, 27). Three studies assessed the use of an ACD both in EVAR and in TEVAR (1, 8, 17) (Table 2).
Patient characteristics
The majority of patients were male (78%) (Table 3). Reported patient comorbidity consisted of smoking (range 12.8% - 77.2%) (19, 24), diabetes mellitus (range 4.5% - 42.2%) (25, 27), hypertension (range 57.1% - 100%) (19, 21), coronary artery disease (range 21.4% - 68.2%) (21, 25), and renal impairment (range 0% - 23.8%) (1, 19). These comorbidities were equally divided between the ACD- and the SCD-groups (Table 3). Other reported characteristics were only available in a minority of studies. These were equally divided and consisted of: hypercholesterolemia (1, 5, 19, 22, 24, 25), abdominal aortic aneurysm (AAA)-size (2, 19, 25), cerebrovascular disease (1, 5, 18, 19, 23-25, 27), chronic obstructive pulmonary disease (1, 2, 18-20, 24, 27), and intermittent claudication (1, 5, 21, 24, 25).
Author (year) Sex (male) Smoking Diabetes Hypertension CAD Renal imp.
ACD SCD ACD SCD ACD SCD ACD SCD ACD SCD ACD SCD
Larzon (2015) 82.4 83.3 31.4 27.1 15.7 12.5 74.5 77.1 52.9 54.2 11.8 6.3 Nelson (2014) 90.1 90.0 77.2 68.0 28.7 22.0 86.1 88.0 44.6 48.0 1.0 4.0 Holper (2014) 42.9 71.4 na na 14.3 64.3 100.0 100.0 21.4 42.9 na na Torsello (2003) na na na na na na na na na na na na Jean-B. (2008) 94.7 95.2 57.9 57.1 5.3 9.5 94.7 66.7 57.9 66.7 10.5 19.0 Morasch (2004) 76.6 94.3 12.8 22.9 19.1 20.0 61.7 57.1 57.4 57.1 0.0 0.0 Metcalfe (2013) 80.8 87.4 na na 14.4 12.5 na na 42.4 46.1 1.1 1.9 Spitzer (2016) 32.7 40.7 na na 42.2 41.5 98 98.5 39.7 47.4 0.5 2.2 Etezadi (2011) 82.9 86.9 na na na na na na na na na na Ni ZH (2011) 84.7 89.4 67.1 54.3 9.4 5.3 77.6 80.8 7.1 7.3 5.9 4.6 Bensley (2012) 81.1 77.0 na na 19.6 22.2 82.8 69.1 45.4 43.7 19.0 23.8 Kontopod. (2015) na na na na na na na na na na na na Mousa (2013) 81.2 81.8 na na 22.6 36.4 na na na na 6.0 1.5 Nakamura (2014) 57.9 59.0 na na 40.7 40.3 87.9 95.5 58.6 67.2 na na Rachel (2002) na na na na na na na na na na na na Buck (2015) 81.0 81.0 na na 16.0 16.0 81.0 81.0 na na 1.4 1.2 Smith (2009) 86.4 95.5 31.8 31.8 22.7 4.5 72.7 81.8 68.2 45.5 na na Overall 75.4 80.9 46.4 43.5 20.8 23.6 83.4 81.4 45.1 47.8 5.7 6.5 Procedural characteristics
In 2939 access-procedures an ACD was used and in 4950 access procedures an open approach to the CFA was performed (SCD-group). In the SCD group only 1
Table 3. Patient characteristics. Data are presented in percentages; CAD= coronary artery disease; NA= not available.
study used the fascia closure technique (18). Most procedures were performed in the operating theatre (62.5%, 10 studies) (1-3, 8, 17, 19, 20, 24-26). One TAVR-study performed its implantations in the catheterization room, (23) and 6 studies did not mention the location of the intervention (4, 5, 18, 21, 22, 27). The following ACD devices were used in the studies: ProGlide™ (2-4 devices per groin) or ProS-tar™ (1 or 2 devices per groin)(both from Abbott Vascular Inc., Redwood City, CA, USA). Overall conversion to open access was reported in 168 percutaneous procedures using ACD (5.7%). Forty-four per cent of these conversions were due to persistent haemorrhage and 8% mentioned a technical failure, but in 48% of the cases no reason for conversion was reported. For the analysis these conversions were not qualified as complications and were handled according to an “intention to treat” principle.
Primary outcome
There was a statistically significant difference regarding seroma development in favour of ACD compared to SCD (OR=0.15, 95% CI 0.06-0.35, Fig. 2).
Figure 2. Forest plot of the meta-analysis concerning seroma formation. The randomized controlled
trials are not significantly in favor of arteriotomy closure devices (ACDs); the overall analysis shows a clear advantage, but sample size is small. SCD= surgical cut down; CI= confidence interval.
Nevertheless, this effect was mainly due to the cohort studies. The two
randomized trials (17, 24) did not show a difference in seroma formation (pooled OR=0.15, 95%CI: 0.02-1.31). However, the sample size was also small.
Three studies (2, 8, 23) included data on wound dehiscence, showing a statistically significant difference, again favouring the ACD group (OR=0.14, 95%CI 0.03-0.78) (Table 4).
Table 4. Number of post-operative complications. RCT = randomized controlled trial; ACD =
arteriotomy closure device; SCD = surgical cut down; OR = odds ratio; SSI = surgical site infection; CFA complication = dissection, fistula, occlusion, or stenosis of the common femoral artery (CFA). * Number of complications. ** Total number of CFA accesses.
Complication RCT Non-RCT Total
ACD SCD OR p ACD SCD OR p OR p Seroma 0* 128** 4 78 0.15 0.09 3 1018 85 1282 0.15 <0.01 0.15 <0.01 Dehiscence 0 0 - - 0 1379 24 3363 0.14 0.03 0.14 0.03 SSI 1 179 0 126 1.30 0.52 14 2508 98 4632 0.36 <0.01 0.38 <0.01 Pseudo-aneurysm 5 152 1 98 2.89 0.25 20 1111 3 1455 4.14 <0.01 3.83 <0.01 Hematoma 1 194 4 141 0.47 0.31 42 1531 65 1721 0.80 0.57 0.76 0.37 Neuropathy 0 152 2 98 0.22 0.20 0 94 4 70 0.18 0.26 0.20 0.07 CFA compl. 8 194 6 141 0.60 0.77 60 2368 48 4366 1.41 0.17 1.19 0.23 Iliac rupture 1 116 3 65 0.31 0.25 29 284 30 260 0.80 0.44 0.75 0.29 Conversions 17 8.8% 151 5.5% 168 5.7%
Compared to the SCD group, the ACD group had a significant 62% lower likelihood of developing a SSI (OR=0.38, 95%CI 0.23-0.63)(Figure 3).
Figure 3. Forest plot of the meta-analysis concerning surgical site infection. A statistically significant
difference between the arteriotomy closure device (ACD) and surgical cut down (SCD) group is found, favouring the ACD group. CI= confidence interval.
There was a significant increase in pseudoaneurysm formation seen in the ACD group (OR=3.8, 95%CI 1.6-9.4). Most studies favoured the SCD group (Figure 4). There were no differences regarding postoperative hematoma (OR=0.76, 95%CI 0.39-1.48), femoral neurop-athy (OR=0.2, 95%CI 0.04-1.03), postoperative stenosis or occlusion of the CFA (OR=1.19, 95%CI 0.73-1.96), or iliac rupture (OR=0.75, 95%CI 0.44-1.28) between the two groups (Table 4).
When only the studies with a low risk of bias were pooled, none of the primary outcome remained significant (Figures 2-4 and Table 4)
Figure 4. Forest plot of the meta-analysis concerning pseudoaneurysm. A significant advantage for
surgical cut down (SCD) was found concerning pseudoaneurysm formation. ACD= arteriotomy closure device; CI= confidence interval.
Figure 5. Forest plot of the meta-analysis concerning duration of surgery (DOS). Note. No significant
difference in randomised trials or in all studies together. ACD= arteriotomy closure device; SCD= surgical cut down; CI= confi-dence interval.
Discussion
This study is the first meta-analysis to compare the outcome of ACD with SCD after EVAR, TEVAR and aortic valve replacement. A trend towards fewer complications was seen in the ACD group (i.e. seroma, dehiscence, femoral neuropathy, and SSI’s). This difference was not detected in RCTs only. Pooled analysis of five of 17 studies did not show a significant reduction in DOS or hospital stay. When analysing studies non-parametrically, the difference was not significant.
Opinions concerning applicability of ACDs in patients changed over time. Early studies reported an increase in complications when using percutaneous closure devices (28), especially in the obese and scarred groins (17). CFAs of inferior quality are also often present in calcified arteries, and patients Marfan’s Syndrome or who are morbidly obese (8). However, more recent RCTs report no difference or even an advantage for these particular patients (18, 21, 24). This is important because avoidance of open femoral exposure can decrease the risk for inguinal complications after repeat operations and femoral punctures in a scarred groin (17). The only significant advantage for SCD is the reduced risk of pseudoaneurysm formation, probably because the repair is performed under direct vision (except when the fascia closure technique is used).
Despite the risk of conversion to open access, ACD caused fewer complications. A total of 168 conversions were reported in a total of 2939 ACDs: a conversion rate of 5.7%. A total of 397 complications were seen in SCD (8.0%) compared with 201 after ACD use (6.8%). This gain was reported previously both in endovascular aneurysm surgery and TAVR (1, 29). Reduction of seroma formation, wound dehiscence and SSI results in less intensive (and expensive) wound surveillance, and may eventually result in a cost reduction in the end. Although this could counterbalance the investment of the ProGlide™ or ProStar™ devices, the increased number of pseudoaneurysms comes with its own additional costs. At present, there is insufficient understand-ing of the additional costs involved, but one study reported increased safety for the ProGlide™device (24).
ACDs appear to have an advantage over SCD in both DOS (10 minutes) and HLOS (0.5 day). Unfortunately, only five of the 17 included studies reported a SD and neither the reduction in DOS and HLOS was significant when comparing the majority of studies non-parametrically. One study specifically related a reduction in DOS and HLOS to specific strategies in healthcare (8), suggesting some form of publication bias. A recent Cochrane analysis also concluded a reduction of DOS, but this result was based on one RCT only (24, 30).
Limitations
Firstly, different types of studies were included wherein the comparability may be questionable, resulting in a high heterogeneity. In general, randomized trials are often limited by the underrepresentation of elderly and high-risk patients, but in the trials used for this review these characteristics were present and equally divided. Cohort studies analysed patients from two different time-periods, thus evoking unequal treatment protocols. Selection of suitable CFA vessels was only reported in one study and it was therefore excluded. Cohort stud-ies should avert this selection bias, because most of these studies compared an earlier SCD period to a later ACD period. Whether exclusion of unsuitable CFAs was present, was not stated in any of the studies. Cohort studies do increase the worldwide applicability of the results. Secondly, detection bias is difficult to ignore and hard to solve. Blinding of outcome remains a problem in surgical research and was absent in all of the included studies. The studies failed to mention laboratory tests or the evaluation of wounds by an objective wound-specialist.
Figure 6. Forest plot shows a significant reduction of hospital length of stay (HLOS) in randomised
trials, but not in all studies together: 0.53 days. ACD= arteriotomy closure device; SCD= surgical cut down; CI= confidence interval.
Thirdly, there is reason to believe that the studies included with low risk of selection bias were underpowered. A maximum of 50 patients was included in each group in these randomised studies. Nevertheless, a power analysis performed for the PiERO-trial mandated 118 patients per group to avoid a type II error (31). Finally, retrospective cohorts often underreport complications. The SCD groups of the cohort studies were generally historic cohorts preceding the introduction of ACDs. Prospective analysis of such a retrospective cohort carries the risk of missing data (e.g., complications) of critical importance for a proper comparison. Despite this possible advantage for the SCD group, a reduction of complications was demonstrated in the ACD group.
Owing to these shortcomings, further randomized research is needed with an accurate and thorough registra-tion of complications. Currently the authors’ group has launched a prospective multicentre study in which both techniques, ACD and SCD, are compared in one patient (31). An advantage from the patients’ perspective might also be expected, and will be examined in the multicentre PiERO trial.
Conclusion
Patients treated with an ACD need a conversion to open access in 5.7% of the cases. A trend towards fewer wound complications is seen after ACD but more pseudoaneurysms are found when compared with SCD. A small reduction in DOS and HLOS might be achieved but will be of limited clinical significance. Because of the moderate quality of evidence, and the possible exclusion of diseased CFA vessels, the present review sup-ports the ACD in suitable patients regarding CFA access, but further randomized research is needed.
References
1. Bensley RP, Hurks R, Huang Z, Pomposelli F, Hamdan A, Wyers M, Chaikof
E, Schermerhorn ML. Ultrasound-guided percutaneous endovascular aneurysm repair success is predicted by access vessel diameter. J Vasc Surg. 2012;55:1554-61.
2. Buck DB, Karthaus EG, Soden PA, Ultee KHJ, van Herwaarden JA, Moll FL,
Schermerhorn ML. Percutaneous versus femoral cutdown access for endovascular aneurysm repair. J Vasc Surg. 2015;62:16-21.
3. Etezadi V, Katzen BT, Naiem A, Johar A, Wong S, Fuller J, Benenati JF.
Percutaneous suture-mediated closure versus surgical arteriotomy in endovascular aortic aneurysm repair. J Vasc Interv Radiol. 2011;22:142-7.
4. Kontopodis N, Tsetis D, Kehagias E, Daskalakis N, Galanakis N, Ioannou
CV. Totally percutaneous endovascular aneurysm repair using the preclosing technique: Towards the least invasive therapeutic alternative. Surg Laparosc Endosc Percutan Tech. 2015;25:354-7.
5. Nakamura M, Chakravarty T, Jilaihawi H, Doctor N, Dohad S, Fontana G,
Cheng W, Makkar RR. Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: A comparison with surgical cut-down and closure. Cath Cardiovasc Intervent. 2014;84:293-300.
6. Wilson JS, Johnson BL, Parker JL, Back MR, Bandyk DF. Management of
vascular complications following femoral artery catheterization with and without percutaneous arterial closure devices. Ann Vasc Surg. 2002;16:597-600.
7. Eisenack M, Umscheid T, Tessarek J, Torsello GF, Torsello GB.
Percutaneous endovascular aortic aneurysm repair: A prospective evaluation of safety, efficienty, and risk factors. J Endovasc Ther. 2009;16:708-13.
8. Metcalfe MM, Brownrigg JRW, Black SA, Loosemore T, Loftus IM, Thompson
MM. Unselected percutaneous access with large vessel closure for endovascular aortic surgery: Experience and predictors of technical success. Eur J Vasc Endovasc Surg. 2012;43:378-81.
9. Georgiadis GS, Antoniou GA, Papaioakim M, Georgakarakos E, Trellopoulos
G, Papanas N, Lazarides MK. A meta-analysis of outcome after percutaneous endovascular aortic aneurysm repair using different size sheaths or endograft delivery systems. J Endovasc Ther. 2011;18:445-59.
10. Dickersin K, Scherer R, Lefebvre C. Systematic reviews: Identifying relevant
studies for systematic reviews. BMJ. 1994;309:1286-91.
11. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher
in Epidemiology (MOOSE) Group. Meta-analysis of observational studies in epide-miology. JAMA. 2000;283:2008-12.
12. Moher D, Liberati A, Tetzlaff J, Altman DG for the PRISMA Group. Preferred
reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
13. Wells GA, Shea B, O’Connell D, Peterson J, Welch V, Losis M, Tugwell P.
The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomized studies in meta- analyses
http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp [
14. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, Savović
J, Schulz F, Weeks L, Sterne JAC. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:1-9.
15. Viechtbauer W. Conducting meta-analysis in R with the metafor package. J
Stat Soft. 2010;36:1-48.
16. Sterne J, AC, Sutton AJ, Ioannidis JPA, Terrin N, Jones DR, et al.
Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials. BMJ. 2011;342:1-8.
17. Torsello GB, Kasprzak B, Klenk E, Tessarek J, Osada N, Torsello GF.
Endovascular suture versus cutdown for endovascular aneurysm repair: A prospective randomized pilot study. J Vasc Surg. 2003;38:78-82.
18. Larzon T, Roos H, Gruber G, Hendrikson O, Magnuson A, Falkenberg M,
Lönn L, Norgren L. A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair. Eur J Vasc Endovasc Surg. 2015;49:166-73.
19. Morasch MD, Kibbe MR, Evans ME, Meadows WS, Eskandari K, Matsumura
JS, Pearce WH. Percutaneous repair of abdominal aortic aneurysm. J Vasc Surg. 2004;40:12-6.
20. Jean-Baptiste E, Hassen-Khodja R, Haudebourg P, Bouillanne P-J, Declemy
S, Batt M. Percutaneous closure devices for endovascular repair of infrarenal abdominal aortic aneurysms: A prospective, non-randomized comparative study. Eur J Vasc Endovasc Surg. 2008;35:422-8.
21. Holper EM, Kim RJ, Mack M, Brown D, Brinkman W, Herbert M, Stewart W,
Vance K, Bowers B, Dewey T. Randomized trial of surgical cutdown versus
percutaneous access in transfemoral TAVR. Cath Cardiovasc Intervent. 2014;83:457-64.
22. Mousa AY, Campbell JE, Broce M, Abu-Halimah S, Stone PA, Hass SM,
AbuRahma AF, Bates M. Predictors of percutaneous access failure requiring open
femoral surgical conversion during endovascular aortic aneurysm repair. J Vasc Surg. 2013;58:1213-9.
23. Ni ZH, Luo JF, Huang WH, Liu Y, Xue L, Fan RX, Chen JY. Totally
percutaneous thoracic endovascular aortic repair with the preclosing technique: A case-control study. Chin Med J. 2011;124:851-5.
24. Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P,
Bacharach M. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014;59:1181-94.
25. Smith ST, Timaran CH, Valentine RJ, Rosero EB, Clagett P, Arko FR.
Percutaneous access for endovascular abdominal aortic aneuysm repair: Can selection criteria be expanded? Ann Vasc Surg. 2008;23:621-6.
26. Rachel ES, Bergamini TM, Kinney EV, Jung MT, Kaebnick HW, Mitchell RA.
Percutaneous endovascular abdominal aortic aneurysm repair. Ann Vasc Surg. 2002;16:43-9.
27. Spitzer S, G, Wilbring M, Alexiou K, Stumpf J, Kappert U, Matschke K.
Surgical cut-down or percutaneous access - which is best for less vascular access complications in transfemoral TAVI? Cath Cardiovasc Intervent. 2016;88:E52-E8.
28. Börner G, Ivancev K, Sonesson B, Lindblad B, Griffin D, Malina M.
Percutaneous AAA repair: Is it safe? J Endovasc Ther. 2004;11:621-6.
29. Bernardi FL, Gomes WF, de Brito Jr FS, Mangione JA, Sarmento-Leite R,
Siqueira D, Carvalho LA, Tumelero R, Guerios EE, Lemos PA. Surgical cutdown versus percutaneous access in transfemoral transcatheter aortic valve implantation: Insights from the Brazilian TAVI registry. Cath Cardiovasc Intervent. 2015;86:501-5.
30. Robertson L, Andras A, Colgan F, Jackson R. Vascular closure devices for
femoral arterial puncture site haemostasis (Review). Cochrane database of
systematic reviews. 2016(3):CD009541. DOI: 10.1002/14651858.CD009541.pub2.
31. Vierhout BP, Saleem BR, Ott A, van Dijl JM, van Andringa de Kempenaer
TD, Pierie MEN, Bottema JT, Zeebregts CJ. A comparison of Percutaneous
femoralaccess in Endovascular Repair versus Open femoral access (PiERO): Study protocol for a randomized controlled trial. Trials. 2015;16:408-17.
