Cardiovasc Intervent Radiol DOI 10.1007/s00270-014-1004-0
CLINICAL INVESTIGATION
Efficacy and Safety of Augmenting the Preclose Technique with a Collagen-Based Closure Device for Percutaneous Endovascular Aneurysm Repair Rafiuddin Patel • Maciej T. Juszczak • Mark J. Bratby • Ediri Sideso • Susan Anthony • Charles R. Tapping • Ashok Handa • Christopher R. Darby Jeremy Perkins • Raman Uberoi
•
Received: 20 October 2013 / Accepted: 31 August 2014 Ó Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2014
Abstract Purpose To report our experience of selectively augmenting the preclose technique for percutaneous endovascular aneurysm repair (p-EVAR) with an Angio-Seal device as a haemostatic adjunct in cases of significant bleeding after tensioning the sutures of the suture-mediated closure devices. Materials and Methods Prospectively collected data for p-EVAR patients at our institute were analysed. Outcomes included technical success and access site complications. A logistic regression model was used to analyse the effects of sheath size, CFA features and stent graft type on primary failure of the preclose technique necessitating augmentation and also on the development of complications. Results p-EVAR was attempted via 122 CFA access sites with a median sheath size of 18-French (range 12- to 28-French). Primary success of the preclose technique was 75.4 % (92/122). Angio-Seal augmentation was utilised as an adjunct to the preclose technique in 20.5 % (25/122). The overall p-EVAR success rate was 95.1 % (116/122). There was a statistically significant relationship (p = 0.0093) between depth of CFA and primary failure of preclose technique. CFA diameter, calcification, type of stent graft and sheath size did not have significant effects
R. Patel (&) M. J. Bratby S. Anthony C. R. Tapping R. Uberoi Department of Radiology, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Headley way, Headington OX3 9DU, UK e-mail: [email protected] M. T. Juszczak E. Sideso A. Handa C. R. Darby J. Perkins Department of Vascular Surgery, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Headley way, Headington OX3 9DU, UK
on primary preclose technique failure. Overall 4.9 % (6/ 122) required surgical conversion but otherwise there were no major complications. Conclusion Augmentation with an Angio-Seal device is a safe and effective adjunct to increase the success rate of the preclose technique in p-EVAR. Keywords Abdominal aortic aneurysms Aneurysms Arterial intervention Endovascular aneurysm repair/endovascular aortic repair Graft/ endograft Percutaneous endovascular aneurysm repair Thoracic endovascular aortic repair
Introduction Endovascular aortic aneurysm repair (EVAR) is an established minimally invasive treatment with lower morbidity and mortality, at least in the short term, compared to open repair [1, 2]. Surgical access to the femoral artery for EVAR (S-EVAR) is the original approach described for the delivery of large stent graft devices. Wound-related complications due to S-EVAR can be significant, with a reported incidence of 4–20 %, leading to increased morbidity and prolonged hospital stay [3, 4]. In light of this, percutaneous EVAR (p-EVAR) techniques have been developed. Further potential advantages of p-EVAR are reductions in operating time, blood loss, time to ambulation and hospital stay [3–6]. p-EVAR is usually performed with suture-mediated closure devices (SMCD’s) utilising the ‘preclose technique’. Prostar XL (Abbott Vascular, CA, USA) is the first SMCD licenced in Europe for closure of access sites up to 24-French with this technique. Perclose Proglide (Abbott Vascular, CA, USA) is a SMCD originally licenced for
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5- to 8-French access sites that has been successfully used and recently licenced to close p-EVAR access sites up to 21-French with the preclose technique [7–10]. Overall reported success rates for the preclose technique are between 88 and 94 % [3, 10, 11]. There is a known learning curve and failure rate of the preclose technique, particularly when there are adverse features such as calcification of the common femoral artery (CFA), scarring from previous surgery and obesity [11]. Augmentation of the preclose technique with a further SMCD, at the end of the procedure when haemostasis is inadequate, has been described but use of a collagen-based closure device, such as Angio-Seal (St Jude Medical, MN, USA), to augment the preclose technique has not been previously reported to our knowledge. The study objective is to present our early experience of p-EVAR, in particular using Angio-Seal as a haemostatic adjunct to augment the conventional SMCD preclose technique, and also to analyse factors associated with failure of the preclose technique and the development of complications.
Materials and Methods The preclose technique has been well described in the literature with minor variations [7, 12, 13]. The preclose technique with two Proglide devices is the method we routinely use in our institution and is briefly described. Standard Preclose Technique Following percutaneous CFA access at the beginning of the procedure, two Proglide devices are pre-deployed at the same access site. Each device is angled approximately 30–60° from the anterior midline in opposite directions. The sutures are left untied during the procedure. Following completion of EVAR, the sheath is removed over a wire, whilst the pre-deployed sutures are tensioned. The adequacy of haemostasis is assessed at this stage after removal of any external pressure and with the wire in situ. If haemostasis is considered satisfactory, the wire is removed, sutures are tensioned, locked and cut. Angio-Seal Augmented Preclose Technique At the end of the procedure, if there is significant bleeding following tensioning of both sutures then augmentation with an 8-French Angio-Seal device is considered. The AngioSeal sheath is inserted over the wire with caution to ensure there is no disruption of the Proglide sutures. The collagen plug of the device is inserted through the Angio-Seal sheath following removal of the wire and the Angio-Seal is
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deployed in a conventional manner. If there is resistance to the insertion of the 8-French Angio-Seal then trial insertion of a 6-French Angio-Seal is attempted and this would be deployed if there is no resistance to insertion. If resistance is encountered to the 6-French Angio-Seal, then this would be abandoned in favour of manual compression. Data Collection and Analysis A prospectively collected database of all elective and acute patients undergoing EVAR for abdominal and thoracic aneurysms at our institution, between August 1st 2011 and March 31st 2013, was evaluated to review all p-EVAR cases. Additional data were collected from electronic radiology and surgery databases, clinic letters and patient notes. Data collected included patient demographics, depth of CFA from skin, CFA diameter, degree of CFA calcification, sheath size, technical success, surgical conversions and any access site complications. CFA characteristics were evaluated on the pre-procedural and follow-up CT angiogram studies by a consultant radiologist blinded to the procedural technique and outcomes. Sheath size is reported as the inner diameter in French size, rather then outer diameter, as this is the common method of reporting sheath size in the published literature [11]. Fat distribution at the femoral access site can vary amongst patients despite a similar body mass index. The depth of the CFA was therefore measured vertically from the skin on the pre-operative CT as a guide to patient obesity as described by Smith et al. [14]. The pattern of CFA calcification was assessed on pre-procedural CT and recorded as either none, anterior, posterior or circumferential. Primary success of the preclose technique was defined as percutaneous closure of the CFA without the need for any further closure device or open surgical conversion. Overall success of the p-EVAR technique was defined as successful percutaneous closure of the CFA without the need for open surgical conversion. Access site complications detected clinically or on imaging, regardless of symptoms, were recorded. Complications were stratified as either minor or major based on outcome according to Society of Interventional Radiology guidelines [15, Appendix]. To assess any change in diameter at the access site that may be due to the addition of the collagen-based closure device, the CFA was measured on pre- and post-procedural imaging for all patients who had Angio-Seal augmentation. A discrepancy of more than 1 mm on comparative imaging was recorded as a true change in calibre. Statistical analysis was performed using R statistical software (v. 3.0.1; Free Software Foundation GNU-project). A logistic regression model was used to analyse the effect of anatomical factors, stent graft type and sheath size
R. Patel et al.: Angioseal Augmented p-EVAR
Fig. 1 Diagram depicting the patient pathway and outcomes for type of technique utilised to achieve haemostasis for attempted p-EVAR
on failure of the preclose technique and the development of complications. P values of less than 0.05 were considered significant. Chi-squared and Wald tests were used to calculate inferential statistics.
Results p-EVAR was attempted via 122 CFA access sites (each with sheath size greater than 12-French) in a total of 65 patients during the study period. An overview of the p-EVAR patient pathways with techniques required to achieve access site haemostasis is depicted in Fig. 1. The primary success rate of the preclose technique, without an additional device or surgical conversion, was 75.4 % (92/122). Logistic regression demonstrated a positive correlation between CFA depth and primary failure of the preclose technique (Coefficient estimate = 0.05 ± 0.02, z value = 2.301; p \ 0.05). CFA diameter, CFA calcification, type of stent graft and sheath size did not have significant effects on primary preclose failure. Angio-Seal augmentation was utilised as an adjunct to the preclose technique in 20.5 % (25/122). Three patients in this group (13.0 %) had groin scarring from previous surgery. When utilised, Angio-Seal augmentation resulted in satisfactory haemostasis without need for open conversion in 96 % of cases (24/25). The single failure of the Angio-Seal augmented preclose technique was in a patient with anterior wall CFA calcification and a scarred groin due to multiple previous episodes of surgery, where the residual arteriotomy following tensioning of both Proglide
sutures were too large for the footplate of the Angio-Seal device to be deployed. When operators were not familiar with the Angio-Seal augmentation technique, manual compression only was applied due to significant bleeding following tensioning of the sutures at 4.1 % (5/122) of the access sites. All of these cases required surgical conversion for haemostasis. The overall p-EVAR success rate was 95.1 % (116/122). Patient and procedure-related data for patients who underwent standard preclose technique and Angio-Seal augmented preclose technique are summarised in Table 1. Failure of the percutaneous technique required conversion to surgical femoral exposure in 4.9 % (6/122) of cases as already described but otherwise there were no major access-related complications. The total rate of minor complications was 6.6 % (8/122). Complications other than surgical conversion and how these related to the technique of closure are presented in Table 2. Primary failure of the preclose technique led to a nearly sixfold increase in the risk of developing minor complications compared to primary preclose technique success (odds ratio = 5.95, ChiSquared = 4.63, p = 0.0315). There was no statistical correlation between CFA anatomical factors, graft type or sheath size and the complication rates. The minimum duration of follow-up for all patients was 3 months (range 3–24 months). There were no delayed access site complications beyond the immediate post-procedural period. There was no recorded change in calibre (variability more then 1 mm) at any CFA access site when compared on pre- and post-procedural CT following Angio-Seal augmentation of the preclose technique (mean
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R. Patel et al.: Angioseal Augmented p-EVAR Table 1 Patient and procedure-related data for patients who underwent p-EVAR with standard preclose technique and p-EVAR with Angio-Seal augmentation of the preclose technique
Number of CFA access sites
Standard preclose technique
Angio-Seal augmentation of preclose technique
97
25
Age [median (range)]
79.3 (59.8–89.9)
79.9 (59.7–89.6)
Sex
88.1 % male
95.7 % male
CFA diameter (mm) [mean ± SD]
12.8 ± 2.1
13.0 ± 2.4
CFA depth (mm) (mean ± SD)
29.0 ± 9.1
35.3 ± 12.5
No calcification
42.27 % (41)
36.00 % (9)
Anterior CFA calcification
3.09 % (3)
4.00 % (1)
Posterior CFA calcification
43.30 % (42)
36.00 % (9)
Circumferential CFA calcification
11.34 % (11)
24.00 % (6)
Sheath size (French) [median (range)]
18.0 (14-28)
17.0 (12-25)
Infra-renal EVAR
91.50 % (38)
96.00 % (24)
Fenestrated EVAR
4.80 % (2)
0.00 % (0)
Thoracic EVAR
4.80 % (2)
4.00 % (1)
Zenith Flex (Cook Medical Inc., IN, USA)
52.6 % (51)
64 % (16)
Endurant (Medtronic, MN, USA)
16.5 % (16)
20 % (5)
Zenith LP (Cook Medical Inc., IN, USA)
17.5 % (17)
8 % (2)
Aorfix (Lombard Medical, Didcot, UK)
7.22 % (7)
4 % (1)
Anaconda (Vascutek, Renfrewshire, UK)
4.12 % (4)
0
Valiant (Medtronic, MN, USA)
2.06 % (2)
4 % (1)
Anatomical characteristics
Procedural characteristics
Type of stent graft
follow-up period for this group of patients was 9.7 months, range 3–24 months).
Discussion The preclose technique for p-EVAR is a well-accepted method of successfully avoiding potential disadvantages of S-EVAR. One of the crucial procedural steps of this technique is tensioning of sutures performed with a wire in the access vessel. If required, this allows the operator to insert a further closure device for haemostasis, or to insert a sheath or occlusion balloon for haemostasis whilst a surgical cutdown is performed. Previous literature has
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described the insertion of a further SMCD to treat ongoing bleeding following tensioning of the pre-deployed sutures, but many case series do not detail how often this is required. Lee et al. reported that 5 out of 279 CFA access sites (1.8 %) in their series required a third Perclose device to achieve haemostasis [7]. Insertion of a collagen-based vascular closure device to control continued bleeding following the preclose technique has not been previously described to our knowledge. The rationale for using the Angio-Seal rather than an additional SMCD in our practice is the dual mechanism of action of Angio-Seal which provides physical approximation due to the footplate/collagen plug assembly as well as procoagulant properties of the collagen to enhance local haemostasis. Additionally, in our experience of vessel closure outside of EVAR, the Angio-Seal device has been used to successfully close access sites slightly larger than the recommended sheath sizes, with an 8-French AngioSeal closing up to 12-French sheath sites. This use of Angio-Seal is outside of its licenced indication but has been reported to be feasible and safe [16]. When utilising an additional closure device to augment the preclose technique at the end of the procedure, there is potential risk this may disrupt the previously tied sutures. We have not found this to be the case in our series. This may be because the Angio-Seal was judiciously used only when bleeding was considered significant and the residual space between the sutures and arteriotomy would accommodate the Angio-Seal device. In addition, the Angio-Seal device is regularly used for routine vascular procedures in our department and operators are familiar with the degree of tension required to insert and deploy the device. Technical success of p-EVAR is known to be variable with a documented learning curve leading to an increased likelihood of complications in the early experience of the operator in p-EVAR [17]. This series represents the early experience of p-EVAR at our institute, yet our overall success rate (95.1 %) compares favourably to the reports in the published literature with pooled technical success rates of 88–94 % [3, 10, 11]. Obesity has previously been established to correlate significantly with p-EVAR failure [18], and this has also been demonstrated in our series with a significantly higher risk of primary preclose technique failure with increasing CFA depth although we managed to avoid the need for surgical conversion in the majority of these cases with the use of an Angio-Seal device. Access-related complications in p-EVAR, not including surgical conversion, have been reported between 3.6 and 5.2 % [3, 11], slightly lower than the rate of minor complications in our series (6.6 %) but our rate of major complications compares favourably. The reporting of p-EVAR complications in the published literature is of a heterogeneous nature making it difficult to draw direct comparisons.
R. Patel et al.: Angioseal Augmented p-EVAR Table 2 Complications for all patients undergoing p-EVAR and complications stratified by type of closure technique Complication
Total p-EVAR group (n = 122 CFA access sites)
Technique Technically successful standard preclose (n = 92)
Primary failure of standard preclose augmented with Angio-Seal (n = 25)
Surgical conversion due to failure of standard preclose and manual compression (n = 5)
Haematoma (treated conservatively, size \5 cm)
3.30 % (4)
2.17 % (2)
4.00 % (1)
20.00 % (1)
Pseudoaneurysm (treated conservatively, size \1.5 cm) Continued bleeding (required manual compression following surgical closure and no further treatment)
2.50 % (3)
1.09 % (1)
8.00 % (2)
0.00 % (0)
0.80 % (1)
0 (0)
0 (0)
20.00 % (1)
Total
6.56 % (8)
3.26 % (3)
12.00 % (3)
40.00 % (2)
Patient selection clearly influences the likelihood of p-EVAR success. We perform p-EVAR routinely as our preferred technique unless there is a clear indication for planned surgical access such as a CFA diameter less than the outer diameter of the sheath to be inserted, CFA occlusive disease requiring endarterectomy or significant anterior wall CFA calcification. Previous groin surgery or obesity are not factors that preclude us from attempting p-EVAR, particularly as these patients are likely to gain the most from avoiding S-EVAR. The limitations of this series include the relatively small sample size, patient selection bias and the possibility that haemostasis may also have been achieved with the use of an additional SMCD although we have outlined the reasoning for our preferential use of the Angio-Seal device. This series also highlights a relatively frequent need for adjunctive measures with the preclose technique that is not widely reported in the literature. Confounding factors that may have contributed to this are that we did not routinely use anticoagulation monitoring or a reversal agent (such as Protamine) to aid haemostasis and not all operators used ultrasound guidance for access. It is possible some cases of bleeding may have responded to prolonged manual compression although in the few cases where this was attempted in our experience it failed. There are reported series where failed p-EVAR has resulted in more blood loss then planned S-EVAR [19, 20]. It is therefore of paramount importance that once a p-EVAR strategy has been chosen it is successful. In this respect, our experience demonstrates that Angio-Seal augmentation provides a valuable adjunct to increase the likelihood of p-EVAR success, helping us to achieve a 95 % success rate even in the early part of our learning curve. It should be borne in mind that this is an off-label use of the Angio-Seal device and potential risks and benefits of this technique should be considered on an individual patient basis in light of operator experience, device familiarity and alternative closure options.
The use of an Angio-Seal device to augment the preclose technique appears safe and efficacious when required to augment the preclose technique in p-EVAR. Conflict of interest of interest.
The authors declare that they have no conflict
Statement of Informed Consent Informed consent was obtained from all the patients included in this report.
Appendix Society of Interventional Radiology Clinical Practice Guidelines classification of complications by outcome [15].
Minor Complications A. No therapy, no consequence B. Nominal therapy, no consequence; includes overnight admission (less then 23 h) for observation only Major Complications A.
Require therapy, minor hospitalisation (more then 24 h but less then 48 h) B. Require major therapy, unplanned increase in level of care, prolonged hospitalisation (more then 48 h) C. Cause permanent adverse sequelae D. Result in death.
References 1. Greenhalgh RM, Brown LC, Kwong GP, EVAR trial participants et al (2004) Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR
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2.
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trial 1), 30-day operative mortality results: randomised controlled trial. Lancet 364:843–848 Prinssen M, Verhoeven EL, Buth J et al (2004) A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med 351:1607–1618 Malkawi AH, Hinchliffe RJ, Holt PJ, Loftus IM, Thompson MM (2010) Percutaneous access for endovascular aneurysm repair: a systematic review. Eur J Vasc Endovasc Surg 39:676–682 Jean-Baptiste E, Hassen-Khodja R, Haudebourg P, Bouillanne PJ, Declemy S, Batt M (2008) Percutaneous closure devices for endovascular repair of infrarenal abdominal aortic aneurysms: a prospective, non-randomized comparative study. Eur J Vasc Endovasc Surg 35(4):422e8 Howell M, Doughtery K, Strickman N, Krajcer Z (2002) Percutaneous repair of abdominal aortic aneurysms using the AneuRx stent graft and the percutaneous vascular surgery device. Catheter Cardiovasc Interv 55(3):281e7 Torsello GB, Kasprzak B, Klenk E, Tessarek J, Osada N, Torsello GF (2003) Endovascular suture versus cutdown for endovascular aneurysm repair: a prospective randomized pilot study. J Vasc Surg 38(1):78e82 Lee WA, Brown M, Nelson PR, Huber TS (2007) Total percutaneous access for endovascular aortic aneurysm repair (‘‘Preclose’’ technique). J Vasc Surg 45(6):1095–1101 Dosluoglu HH, Cherr GS, Harris LM, Dryjski ML (2007) Total percutaneous endovascular repair of abdominal aortic aneurysms using Perclose ProGlide closure devices. J Endovasc Ther 14(2):184e8 Lee WA, Brown MP, Nelson PR, Huber TS, Seeger JM (2008) Midterm outcomes of femoral arteries after percutaneous endovascular aortic repair using the Preclose technique. J Vasc Surg 47(5):919e23 Nelson PR, Kracjer Z, Kansal N et al (2014) A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg 59(5):1181–1193
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11. Jaffan AA, Prince EA, Hampson CO, Murphy TP (2013) The Preclose Technique in percutaneous endovascular aortic repair: a systematic literature review and meta-analysis. Cardiovasc Interv Radiol 36:567–577 12. Hogg ME, Kibbe MR (2006) Percutaneous thoracic and abdominal aortic aneurysm repair: techniques and outcomes. Vascular 14:270–281 13. Morasch MD (2005) Percutaneous thoracic and abdominal aortic aneurysm repair. Ann Vasc Surg 19:585–589 14. Smith ST, Timaran CH, Valentine RJ, Rosero EB, Clagett GP, Arko FR (2009) Percutaneous access for endovascular abdominal aortic aneurysm repair: can selection criteria be expanded? Ann Vasc Surg 23:621–626 15. Sacks D, McClenny TE, Cardella JF, Lewis CA (2003) Society of interventional radiology clinical practice guidelines. J Vasc Interv Radiol 14:S199–S202 16. Sarin SN, Shah RK, Chun A et al (2012) Use of the 8-F angioseal vascular closure device in large-caliber arteriotomies. J Endovasc Ther 19(4):497–500 17. Bechara CF, Barshes NR, Pisimisis G, Chen H, Pak T, Lin PH, Kougias P (2013) Predicting the learning curve and failures of total percutaneous endovascular aortic aneurysm repair. J Vasc Surg 57(1):72–76 18. Howell M, Villareal R, Krajcer Z (2001) Percutaneous access and closure of femoral artery access sites associated with endoluminal repair of abdominal aortic aneurysms. J Endovasc Ther 8(1):68–74 19. Borner G, Ivancev K, Sonesson B, Lindblad B, Griffin D, Malina M (2004) Percutaneous AAA repair: is it safe? J Endovasc Ther 11(6):621e6 20. Morasch MD, Kibbe MR, Evans ME, Meadows WS, Eskandari MK, Matsumura JS et al (2004) Percutaneous repair of abdominal aortic aneurysm. J Vasc Surg 40(1):12e6
CLINICAL INVESTIGATION
Efficacy and Safety of Augmenting the Preclose Technique with a Collagen-Based Closure Device for Percutaneous Endovascular Aneurysm Repair Rafiuddin Patel • Maciej T. Juszczak • Mark J. Bratby • Ediri Sideso • Susan Anthony • Charles R. Tapping • Ashok Handa • Christopher R. Darby Jeremy Perkins • Raman Uberoi
•
Received: 20 October 2013 / Accepted: 31 August 2014 Ó Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2014
Abstract Purpose To report our experience of selectively augmenting the preclose technique for percutaneous endovascular aneurysm repair (p-EVAR) with an Angio-Seal device as a haemostatic adjunct in cases of significant bleeding after tensioning the sutures of the suture-mediated closure devices. Materials and Methods Prospectively collected data for p-EVAR patients at our institute were analysed. Outcomes included technical success and access site complications. A logistic regression model was used to analyse the effects of sheath size, CFA features and stent graft type on primary failure of the preclose technique necessitating augmentation and also on the development of complications. Results p-EVAR was attempted via 122 CFA access sites with a median sheath size of 18-French (range 12- to 28-French). Primary success of the preclose technique was 75.4 % (92/122). Angio-Seal augmentation was utilised as an adjunct to the preclose technique in 20.5 % (25/122). The overall p-EVAR success rate was 95.1 % (116/122). There was a statistically significant relationship (p = 0.0093) between depth of CFA and primary failure of preclose technique. CFA diameter, calcification, type of stent graft and sheath size did not have significant effects
R. Patel (&) M. J. Bratby S. Anthony C. R. Tapping R. Uberoi Department of Radiology, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Headley way, Headington OX3 9DU, UK e-mail: [email protected] M. T. Juszczak E. Sideso A. Handa C. R. Darby J. Perkins Department of Vascular Surgery, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Headley way, Headington OX3 9DU, UK
on primary preclose technique failure. Overall 4.9 % (6/ 122) required surgical conversion but otherwise there were no major complications. Conclusion Augmentation with an Angio-Seal device is a safe and effective adjunct to increase the success rate of the preclose technique in p-EVAR. Keywords Abdominal aortic aneurysms Aneurysms Arterial intervention Endovascular aneurysm repair/endovascular aortic repair Graft/ endograft Percutaneous endovascular aneurysm repair Thoracic endovascular aortic repair
Introduction Endovascular aortic aneurysm repair (EVAR) is an established minimally invasive treatment with lower morbidity and mortality, at least in the short term, compared to open repair [1, 2]. Surgical access to the femoral artery for EVAR (S-EVAR) is the original approach described for the delivery of large stent graft devices. Wound-related complications due to S-EVAR can be significant, with a reported incidence of 4–20 %, leading to increased morbidity and prolonged hospital stay [3, 4]. In light of this, percutaneous EVAR (p-EVAR) techniques have been developed. Further potential advantages of p-EVAR are reductions in operating time, blood loss, time to ambulation and hospital stay [3–6]. p-EVAR is usually performed with suture-mediated closure devices (SMCD’s) utilising the ‘preclose technique’. Prostar XL (Abbott Vascular, CA, USA) is the first SMCD licenced in Europe for closure of access sites up to 24-French with this technique. Perclose Proglide (Abbott Vascular, CA, USA) is a SMCD originally licenced for
123
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5- to 8-French access sites that has been successfully used and recently licenced to close p-EVAR access sites up to 21-French with the preclose technique [7–10]. Overall reported success rates for the preclose technique are between 88 and 94 % [3, 10, 11]. There is a known learning curve and failure rate of the preclose technique, particularly when there are adverse features such as calcification of the common femoral artery (CFA), scarring from previous surgery and obesity [11]. Augmentation of the preclose technique with a further SMCD, at the end of the procedure when haemostasis is inadequate, has been described but use of a collagen-based closure device, such as Angio-Seal (St Jude Medical, MN, USA), to augment the preclose technique has not been previously reported to our knowledge. The study objective is to present our early experience of p-EVAR, in particular using Angio-Seal as a haemostatic adjunct to augment the conventional SMCD preclose technique, and also to analyse factors associated with failure of the preclose technique and the development of complications.
Materials and Methods The preclose technique has been well described in the literature with minor variations [7, 12, 13]. The preclose technique with two Proglide devices is the method we routinely use in our institution and is briefly described. Standard Preclose Technique Following percutaneous CFA access at the beginning of the procedure, two Proglide devices are pre-deployed at the same access site. Each device is angled approximately 30–60° from the anterior midline in opposite directions. The sutures are left untied during the procedure. Following completion of EVAR, the sheath is removed over a wire, whilst the pre-deployed sutures are tensioned. The adequacy of haemostasis is assessed at this stage after removal of any external pressure and with the wire in situ. If haemostasis is considered satisfactory, the wire is removed, sutures are tensioned, locked and cut. Angio-Seal Augmented Preclose Technique At the end of the procedure, if there is significant bleeding following tensioning of both sutures then augmentation with an 8-French Angio-Seal device is considered. The AngioSeal sheath is inserted over the wire with caution to ensure there is no disruption of the Proglide sutures. The collagen plug of the device is inserted through the Angio-Seal sheath following removal of the wire and the Angio-Seal is
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deployed in a conventional manner. If there is resistance to the insertion of the 8-French Angio-Seal then trial insertion of a 6-French Angio-Seal is attempted and this would be deployed if there is no resistance to insertion. If resistance is encountered to the 6-French Angio-Seal, then this would be abandoned in favour of manual compression. Data Collection and Analysis A prospectively collected database of all elective and acute patients undergoing EVAR for abdominal and thoracic aneurysms at our institution, between August 1st 2011 and March 31st 2013, was evaluated to review all p-EVAR cases. Additional data were collected from electronic radiology and surgery databases, clinic letters and patient notes. Data collected included patient demographics, depth of CFA from skin, CFA diameter, degree of CFA calcification, sheath size, technical success, surgical conversions and any access site complications. CFA characteristics were evaluated on the pre-procedural and follow-up CT angiogram studies by a consultant radiologist blinded to the procedural technique and outcomes. Sheath size is reported as the inner diameter in French size, rather then outer diameter, as this is the common method of reporting sheath size in the published literature [11]. Fat distribution at the femoral access site can vary amongst patients despite a similar body mass index. The depth of the CFA was therefore measured vertically from the skin on the pre-operative CT as a guide to patient obesity as described by Smith et al. [14]. The pattern of CFA calcification was assessed on pre-procedural CT and recorded as either none, anterior, posterior or circumferential. Primary success of the preclose technique was defined as percutaneous closure of the CFA without the need for any further closure device or open surgical conversion. Overall success of the p-EVAR technique was defined as successful percutaneous closure of the CFA without the need for open surgical conversion. Access site complications detected clinically or on imaging, regardless of symptoms, were recorded. Complications were stratified as either minor or major based on outcome according to Society of Interventional Radiology guidelines [15, Appendix]. To assess any change in diameter at the access site that may be due to the addition of the collagen-based closure device, the CFA was measured on pre- and post-procedural imaging for all patients who had Angio-Seal augmentation. A discrepancy of more than 1 mm on comparative imaging was recorded as a true change in calibre. Statistical analysis was performed using R statistical software (v. 3.0.1; Free Software Foundation GNU-project). A logistic regression model was used to analyse the effect of anatomical factors, stent graft type and sheath size
R. Patel et al.: Angioseal Augmented p-EVAR
Fig. 1 Diagram depicting the patient pathway and outcomes for type of technique utilised to achieve haemostasis for attempted p-EVAR
on failure of the preclose technique and the development of complications. P values of less than 0.05 were considered significant. Chi-squared and Wald tests were used to calculate inferential statistics.
Results p-EVAR was attempted via 122 CFA access sites (each with sheath size greater than 12-French) in a total of 65 patients during the study period. An overview of the p-EVAR patient pathways with techniques required to achieve access site haemostasis is depicted in Fig. 1. The primary success rate of the preclose technique, without an additional device or surgical conversion, was 75.4 % (92/122). Logistic regression demonstrated a positive correlation between CFA depth and primary failure of the preclose technique (Coefficient estimate = 0.05 ± 0.02, z value = 2.301; p \ 0.05). CFA diameter, CFA calcification, type of stent graft and sheath size did not have significant effects on primary preclose failure. Angio-Seal augmentation was utilised as an adjunct to the preclose technique in 20.5 % (25/122). Three patients in this group (13.0 %) had groin scarring from previous surgery. When utilised, Angio-Seal augmentation resulted in satisfactory haemostasis without need for open conversion in 96 % of cases (24/25). The single failure of the Angio-Seal augmented preclose technique was in a patient with anterior wall CFA calcification and a scarred groin due to multiple previous episodes of surgery, where the residual arteriotomy following tensioning of both Proglide
sutures were too large for the footplate of the Angio-Seal device to be deployed. When operators were not familiar with the Angio-Seal augmentation technique, manual compression only was applied due to significant bleeding following tensioning of the sutures at 4.1 % (5/122) of the access sites. All of these cases required surgical conversion for haemostasis. The overall p-EVAR success rate was 95.1 % (116/122). Patient and procedure-related data for patients who underwent standard preclose technique and Angio-Seal augmented preclose technique are summarised in Table 1. Failure of the percutaneous technique required conversion to surgical femoral exposure in 4.9 % (6/122) of cases as already described but otherwise there were no major access-related complications. The total rate of minor complications was 6.6 % (8/122). Complications other than surgical conversion and how these related to the technique of closure are presented in Table 2. Primary failure of the preclose technique led to a nearly sixfold increase in the risk of developing minor complications compared to primary preclose technique success (odds ratio = 5.95, ChiSquared = 4.63, p = 0.0315). There was no statistical correlation between CFA anatomical factors, graft type or sheath size and the complication rates. The minimum duration of follow-up for all patients was 3 months (range 3–24 months). There were no delayed access site complications beyond the immediate post-procedural period. There was no recorded change in calibre (variability more then 1 mm) at any CFA access site when compared on pre- and post-procedural CT following Angio-Seal augmentation of the preclose technique (mean
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R. Patel et al.: Angioseal Augmented p-EVAR Table 1 Patient and procedure-related data for patients who underwent p-EVAR with standard preclose technique and p-EVAR with Angio-Seal augmentation of the preclose technique
Number of CFA access sites
Standard preclose technique
Angio-Seal augmentation of preclose technique
97
25
Age [median (range)]
79.3 (59.8–89.9)
79.9 (59.7–89.6)
Sex
88.1 % male
95.7 % male
CFA diameter (mm) [mean ± SD]
12.8 ± 2.1
13.0 ± 2.4
CFA depth (mm) (mean ± SD)
29.0 ± 9.1
35.3 ± 12.5
No calcification
42.27 % (41)
36.00 % (9)
Anterior CFA calcification
3.09 % (3)
4.00 % (1)
Posterior CFA calcification
43.30 % (42)
36.00 % (9)
Circumferential CFA calcification
11.34 % (11)
24.00 % (6)
Sheath size (French) [median (range)]
18.0 (14-28)
17.0 (12-25)
Infra-renal EVAR
91.50 % (38)
96.00 % (24)
Fenestrated EVAR
4.80 % (2)
0.00 % (0)
Thoracic EVAR
4.80 % (2)
4.00 % (1)
Zenith Flex (Cook Medical Inc., IN, USA)
52.6 % (51)
64 % (16)
Endurant (Medtronic, MN, USA)
16.5 % (16)
20 % (5)
Zenith LP (Cook Medical Inc., IN, USA)
17.5 % (17)
8 % (2)
Aorfix (Lombard Medical, Didcot, UK)
7.22 % (7)
4 % (1)
Anaconda (Vascutek, Renfrewshire, UK)
4.12 % (4)
0
Valiant (Medtronic, MN, USA)
2.06 % (2)
4 % (1)
Anatomical characteristics
Procedural characteristics
Type of stent graft
follow-up period for this group of patients was 9.7 months, range 3–24 months).
Discussion The preclose technique for p-EVAR is a well-accepted method of successfully avoiding potential disadvantages of S-EVAR. One of the crucial procedural steps of this technique is tensioning of sutures performed with a wire in the access vessel. If required, this allows the operator to insert a further closure device for haemostasis, or to insert a sheath or occlusion balloon for haemostasis whilst a surgical cutdown is performed. Previous literature has
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described the insertion of a further SMCD to treat ongoing bleeding following tensioning of the pre-deployed sutures, but many case series do not detail how often this is required. Lee et al. reported that 5 out of 279 CFA access sites (1.8 %) in their series required a third Perclose device to achieve haemostasis [7]. Insertion of a collagen-based vascular closure device to control continued bleeding following the preclose technique has not been previously described to our knowledge. The rationale for using the Angio-Seal rather than an additional SMCD in our practice is the dual mechanism of action of Angio-Seal which provides physical approximation due to the footplate/collagen plug assembly as well as procoagulant properties of the collagen to enhance local haemostasis. Additionally, in our experience of vessel closure outside of EVAR, the Angio-Seal device has been used to successfully close access sites slightly larger than the recommended sheath sizes, with an 8-French AngioSeal closing up to 12-French sheath sites. This use of Angio-Seal is outside of its licenced indication but has been reported to be feasible and safe [16]. When utilising an additional closure device to augment the preclose technique at the end of the procedure, there is potential risk this may disrupt the previously tied sutures. We have not found this to be the case in our series. This may be because the Angio-Seal was judiciously used only when bleeding was considered significant and the residual space between the sutures and arteriotomy would accommodate the Angio-Seal device. In addition, the Angio-Seal device is regularly used for routine vascular procedures in our department and operators are familiar with the degree of tension required to insert and deploy the device. Technical success of p-EVAR is known to be variable with a documented learning curve leading to an increased likelihood of complications in the early experience of the operator in p-EVAR [17]. This series represents the early experience of p-EVAR at our institute, yet our overall success rate (95.1 %) compares favourably to the reports in the published literature with pooled technical success rates of 88–94 % [3, 10, 11]. Obesity has previously been established to correlate significantly with p-EVAR failure [18], and this has also been demonstrated in our series with a significantly higher risk of primary preclose technique failure with increasing CFA depth although we managed to avoid the need for surgical conversion in the majority of these cases with the use of an Angio-Seal device. Access-related complications in p-EVAR, not including surgical conversion, have been reported between 3.6 and 5.2 % [3, 11], slightly lower than the rate of minor complications in our series (6.6 %) but our rate of major complications compares favourably. The reporting of p-EVAR complications in the published literature is of a heterogeneous nature making it difficult to draw direct comparisons.
R. Patel et al.: Angioseal Augmented p-EVAR Table 2 Complications for all patients undergoing p-EVAR and complications stratified by type of closure technique Complication
Total p-EVAR group (n = 122 CFA access sites)
Technique Technically successful standard preclose (n = 92)
Primary failure of standard preclose augmented with Angio-Seal (n = 25)
Surgical conversion due to failure of standard preclose and manual compression (n = 5)
Haematoma (treated conservatively, size \5 cm)
3.30 % (4)
2.17 % (2)
4.00 % (1)
20.00 % (1)
Pseudoaneurysm (treated conservatively, size \1.5 cm) Continued bleeding (required manual compression following surgical closure and no further treatment)
2.50 % (3)
1.09 % (1)
8.00 % (2)
0.00 % (0)
0.80 % (1)
0 (0)
0 (0)
20.00 % (1)
Total
6.56 % (8)
3.26 % (3)
12.00 % (3)
40.00 % (2)
Patient selection clearly influences the likelihood of p-EVAR success. We perform p-EVAR routinely as our preferred technique unless there is a clear indication for planned surgical access such as a CFA diameter less than the outer diameter of the sheath to be inserted, CFA occlusive disease requiring endarterectomy or significant anterior wall CFA calcification. Previous groin surgery or obesity are not factors that preclude us from attempting p-EVAR, particularly as these patients are likely to gain the most from avoiding S-EVAR. The limitations of this series include the relatively small sample size, patient selection bias and the possibility that haemostasis may also have been achieved with the use of an additional SMCD although we have outlined the reasoning for our preferential use of the Angio-Seal device. This series also highlights a relatively frequent need for adjunctive measures with the preclose technique that is not widely reported in the literature. Confounding factors that may have contributed to this are that we did not routinely use anticoagulation monitoring or a reversal agent (such as Protamine) to aid haemostasis and not all operators used ultrasound guidance for access. It is possible some cases of bleeding may have responded to prolonged manual compression although in the few cases where this was attempted in our experience it failed. There are reported series where failed p-EVAR has resulted in more blood loss then planned S-EVAR [19, 20]. It is therefore of paramount importance that once a p-EVAR strategy has been chosen it is successful. In this respect, our experience demonstrates that Angio-Seal augmentation provides a valuable adjunct to increase the likelihood of p-EVAR success, helping us to achieve a 95 % success rate even in the early part of our learning curve. It should be borne in mind that this is an off-label use of the Angio-Seal device and potential risks and benefits of this technique should be considered on an individual patient basis in light of operator experience, device familiarity and alternative closure options.
The use of an Angio-Seal device to augment the preclose technique appears safe and efficacious when required to augment the preclose technique in p-EVAR. Conflict of interest of interest.
The authors declare that they have no conflict
Statement of Informed Consent Informed consent was obtained from all the patients included in this report.
Appendix Society of Interventional Radiology Clinical Practice Guidelines classification of complications by outcome [15].
Minor Complications A. No therapy, no consequence B. Nominal therapy, no consequence; includes overnight admission (less then 23 h) for observation only Major Complications A.
Require therapy, minor hospitalisation (more then 24 h but less then 48 h) B. Require major therapy, unplanned increase in level of care, prolonged hospitalisation (more then 48 h) C. Cause permanent adverse sequelae D. Result in death.
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