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Editor's Choice – Arteriotomy Closure Devices in EVAR, TEVAR, and TAVR: A Systematic Review and Meta-analysis of Randomised Clinical Trials and Cohort Studies
Department of Surgery, Division of Vascular Surgery, University Medical Centre Groningen, University of Groningen, Hanzeplein 1, 9700 RB Groningen, The Netherlands
Cardiac and vascular surgery benefit from percutaneous interventions. Arteriotomy closure devices (ACDs) enable minimally 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 randomised 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 for meta-analysis, describing 7889 vascular access sites; four studies were randomised trials, two studies reported from 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), less wound dehiscence (OR 0.14, 95% CI 0.03–0.78), and fewer surgical site infections (OR 0.38, 95% CI 0.23–0.63). Post-operative 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.
This paper updates earlier meta-analyses with additional information and increased applicability of outcome after percutaneous access of the common femoral artery. This is particularly important given the establishment of percutaneous procedures and the publication of several important studies reporting use of arteriotomy closure devices.
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 complications, and the hospital length of stay (HLOS), and thereby improve patient satisfaction.
Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.
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 the relationship between sheath size and the necessity for conversion but did not evaluate the complication rate or duration of treatment.
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) guidelines to ensure the quality and completeness for both systematic review and meta-analysis.
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 randomised 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 common femoral artery (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.
Wells GA, Shea B, O'Connell D, Peterson J, Welch V, Losis M, et al. The Newcastle–Ottawa Scale (NOS) for Assessing the Quality of Nonrandomized Studies in Meta- Analyses. Available at: http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.
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.
The included studies were evaluated 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 RCTs 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 vs. SCD) on the occurrence of complications: haematoma, seroma, femoral neuropathy, wound dehiscence, surgical site infection (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 secondary 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,
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.
For dichotomous data ORs were calculated with a 95% CI. In studies that did not mention data, trial information was ignored. Quantitative analyses were confined to data provided by the authors with a SD (DOS and HLOS). When only the interquartile 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. A subgroup analysis was performed separately for the RCTs and the cohort studies.
Results
The systematic search resulted in 746 potentially eligible articles. After initial screening of titles 227 articles were retrieved for abstract review. Of these abstracts a further 194 were excluded based on the inclusion criteria. After full manuscript reading 17 articles were included in the analysis (Fig. 1).
Figure 1Study flow chart (“Preferred Reporting Items for Systematic reviews and Meta-Analysis” diagram).
Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
These had a low risk of selection bias, due to randomisation. Eleven others were retrospective studies. Blinding of outcome was absent in all studies, imposing 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).
Percutaneous access was not performed in emergency surgery in 11 studies and in four studies this information was absent. Calcified CFAs excluded percutaneous access in eight studies. Other exclusion criteria were mentioned in five or fewer of the 17 included studies (< 30%) and consisted of iliac kinking or stenosis, obesity, CFA scarring or diameter < 7 mm, CFA aneurysm, connective tissue disease, mono-iliac device, psychiatric disease, high CFA bifurcation, device > 18 Fr., and pre-existing groin wounds (Table 2).
Table 2Inclusion and exclusion criteria in the various studies.
Author (year)
Inclusion
Exclusion
EVAR
TEVAR
TAVR
rAAA
Calcified CFA
Iliac kinking/stenosis
Obesity
CFA < 7 mm
Scarred CFA
Combined surgery
CFA aneurysm
Connective tissue disease
Mono-iliac device
Psychiatry
COOK, Medtronic, Guidant Ancure
High CFA bifurcation
Device > 18 French
Groin wounds
Larzon (2015)
X
X
X
Nelson (2014)
X
X
X
X
X
Holper (2014)
X
X
Torsello (2003)
X
X
X
X
X
X
Jean-B. (2008)
X
X
X
X
X
X
Morasch (2004)
X
X
X
Metcalfe (2013)
X
X
X
X
X
X
X
Spitzer (2016)
X
?
X
X
X
Etezadi (2011)
X
?
X
Ni ZH (2011)
X
X
X
X
X
Bensley (2012)
X
X
?
X
X
Kontopodis (2015)
X
?
X
X
X
X
Mousa (2013)
X
X
Nakamura (2014)
X
X
X
X
X
Rachel (2002)
X
X
Buck (2015)
X
X
X
X
X
Smith (2009)
X
X
X
X
Total
13
4
2
11
8
5
4
4
3
3
2
2
2
1
1
1
1
1
Note. 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 aneurysm of the abdominal aorta; X = mentioned as exclusion criteria; (?) = not mentioned.
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
These comorbidities were equally divided between the ACD and SCD groups (Table 3). Other reported characteristics were only available in a minority of studies. These were equally divided and consisted of hypercholesterolemia,
Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
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 one study used the fascia closure technique.
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
The following ACD devices were used: ProGlide™ (2–4 devices per groin) or ProStar™ (one or two devices per groin) (both from Abbott Vascular, 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 with SCD (OR 0.15, 95% CI 0.06–0.35; Fig. 2). Nevertheless, this effect was mainly due to the cohort studies. The two randomised trials did not show a difference in seroma formation (pooled OR 0.15, 95% CI 0.02–1.31).
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
Figure 2Forest plot of the meta-analysis concerning seroma formation. Note. The randomised controlled trials are not significantly in favour of arteriotomy closure devices (ACDs); the overall analysis shows a clear advantage, but sample size is small. SCD = surgical cut down; CI = confidence interval.
showing a statistically significant difference, again favouring the ACD group (OR 0.14, 95% CI 0.03–0.78) (Table 4).
Table 4Number of post-operative complications.
Table 4Number of post-operative complications.
Compared with the SCD group, the ACD group had a significantly 62% lower likelihood of developing a SSI (OR 0.38, 95% CI 0.23–0.63) (Fig. 3).
Figure 3Forest plot of the meta-analysis concerning surgical site infection. Note. 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 (Fig. 4).
Figure 4Forest plot of the meta-analysis concerning pseudoaneurysm. Note. A significant advantage for surgical cut down (SCD) was found concerning pseudoaneurysm formation. ACD = arteriotomy closure device; CI = confidence interval.
There were no differences regarding post-operative haematoma (OR 0.76, 95% CI 0.39–1.48), femoral neuropathy (OR 0.2, 95% CI 0.04–1.03), post-operative 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 outcomes remained significant (Figure 2, Figure 3, Figure 4 and Table 4)
Secondary outcomes
DOS
The pooled difference in means was −9.76 min (95% CI −39.2 to 19.7; p = .52) in favour of the ACD group (n = 1366 groins) (Fig. 5).
Figure 5Forest 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 = confidence interval.
Eight studies did not report a SD (n = 5631 groins). From these studies, combined with the five studies above, no formal pooled analysis was possible. The difference according to the Mann–Whitney U test between the ACD and SCD groups was not significant (p = .11).
HLOS
The pooled difference in means was −0.53 days (95% CI −1.28 to 0.22; p = .16) in favour of the ACD group (n = 856 groins) (Fig. 6).
Figure 6Forest plot shows a significant reduction of hospital length of stay (HLOS) in randomised trials, but not in all studies together: 0.53 days. Note. ACD = arteriotomy closure device; SCD = surgical cut down; CI = confidence interval.
Nine studies provided a HLOS but did not report a SD (n = 5894 groins). These studies, combined with the aforementioned five, did not show a significant difference between the ACD and SCD group (p = .29).
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 SSIs). 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 nonparametrically, the difference was not significant.
Opinions concerning the applicability of ACDs have changed over time. Early studies reported an increase in complications when using percutaneous closure devices,
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
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.
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 resulted in fewer complications. A total of 168 conversions were reported in a total of 2939 ACDs: a 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.
Reduction of seroma formation, wound dehiscence, and SSI results in less intensive (and expensive) wound surveillance, and may eventually result in a cost reduction. Although this could counterbalance the investment in the ProGlide™ or ProStar™ devices, the increased number of pseudoaneurysms comes with its own additional costs. At present, there is insufficient understanding of the additional costs involved, but one study reported increased safety for the ProGlide™device.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
ACDs appear to have an advantage over SCD in both DOS (10 min) and HLOS (0.5 days). Unfortunately, only five of the 17 included studies reported a SD and neither the reduction in DOS nor HLOS was significant when comparing the majority of studies nonparametrically. One study specifically related a reduction in DOS and HLOS to specific strategies in health care,
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
Firstly, different types of studies were included wherein the comparability may be questionable, resulting in a high heterogeneity. In general, randomised 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 studies 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 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.
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.
A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.
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 randomised research is needed with an accurate and thorough registration of complications. Currently, the authors' group has launched a prospective multicentre study in which both techniques, ACD and SCD, are compared in one patient.
A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.
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 supports the ACD in suitable patients regarding CFA access, but further randomised research is needed.
Conflict of Interest
None.
Funding
None.
References
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Ultrasound-guided percutaneous endovascular aneurysm repair success is predicted by access vessel diameter.
Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.
Wells GA, Shea B, O'Connell D, Peterson J, Welch V, Losis M, et al. The Newcastle–Ottawa Scale (NOS) for Assessing the Quality of Nonrandomized Studies in Meta- Analyses. Available at: http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.
A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.
A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).
A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.
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