Reference Citation Analysis: Find an Article, Find a Category, Find a Journal, Find a Scholar

For: Watelet J, Gallot JC, Thomas P, Douvrin F, Plissonnier D. Percutaneous Repair of Aortic Aneurysms: A Prospective Study of Suture-Mediated Closure Devices. Eur J Vasc Endovasc Surg 2006;32:261-5. [PMID: 16584898 DOI: 10.1016/j.ejvs.2006.01.022] [Citation(s) in RCA: 62] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [What about the content of this article? (0)] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2005] [Accepted: 01/12/2006] [Indexed: 12/14/2022]

For:	Watelet J, Gallot JC, Thomas P, Douvrin F, Plissonnier D. Percutaneous Repair of Aortic Aneurysms: A Prospective Study of Suture-Mediated Closure Devices. Eur J Vasc Endovasc Surg 2006;32:261-5. [PMID: 16584898 DOI: 10.1016/j.ejvs.2006.01.022] [Citation(s) in RCA: 62] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [What about the content of this article? (0)] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2005] [Accepted: 01/12/2006] [Indexed: 12/14/2022]

Number

Cited by Other Article(s)

Gulmez R, Altunova M, Sahin AA, Celik O. A single center study of the efficacy and safety of Pro-Glide used for closure in thoracic endovascular aortic repair in patients with previous groin intervention. Vascular 2025;33:108-115. [PMID: 38403595 DOI: 10.1177/17085381241236560] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/27/2024]

Barth S, Ahmed M, Hautmann MB, Reents W, Zacher M, Kerber S, Lüsebrink U, Schmandra TC. Prognostic benefits of early vascular surgical intervention in patients with major peripheral vascular complications following transcatheter aortic valve implantation. Hellenic J Cardiol 2024;77:1-12. [PMID: 37611868 DOI: 10.1016/j.hjc.2023.08.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/29/2023] [Revised: 08/08/2023] [Accepted: 08/11/2023] [Indexed: 08/25/2023] Open

Dahlbacka S, Nykänen AI, Juvonen T, Jormalainen M. Access site complications in thoracic endovascular aortic repair. J Vasc Surg 2024;79:740-747.e2. [PMID: 38056701 DOI: 10.1016/j.jvs.2023.11.046] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2023] [Revised: 11/24/2023] [Accepted: 11/29/2023] [Indexed: 12/08/2023]

Abstract

BACKGROUND

Percutaneous access and use of vascular closure devices facilitate thoracic endovascular aortic repair (TEVAR) procedures during local anesthesia and allow immediate detection of signs of spinal ischemia. However, the very large bore access (usually ≥22F sheath) associated with TEVAR increases the risk of vascular complications. In this study, we sought to define the safety and feasibility of two percutaneous femoral artery closure devices during TEVAR, in terms of access site vascular complications and major, life-threatening, or fatal bleeding (≥major) within 48 hours. Access site vascular complications were defined as technical failure of vascular closure or later formation of pseudoaneurysm.

METHODS

From March 2010 to December 2022, 199 transfemoral TEVAR were performed at Helsinki University Central Hospital, Finland. We retrospectively categorized these into three groups, based on surgeon preference for the access technique and femoral artery closure method: (1) surgical cut-down and vessel closure, n = 85 (42.7%), (2) percutaneous access and vascular closure with suture-based ProGlide, n = 56 (28.1%), or (3) percutaneous access and vascular closure with ultrasound-guided plug-based MANTA, n = 58 (29.1%). The primary outcome measure was technical success of vascular closure and access site vascular complications during index hospitalization. Secondary outcome measures were ≥major bleeding, early mortality, and hospital stay.

RESULTS

The technical success rate was 97.6% vs 91.1% vs 93.1% for surgical cut-down, ProGlide, and MANTA, respectively (P = .213). The rate of access site vascular complication was 3.5% vs 8.9% vs 10.3%, respectively (P = .290), with two pseudoaneurysms detected postoperatively and conservatively managed in the MANTA group. The vascular closure method was not associated with increased risk of ≥major bleeding, early mortality, or hospital stay on univariate analysis. Predictors for ≥major bleeding after TEVAR in multivariable analysis were urgent procedure (odds ratio: 2.8, 95% confidence interval: 1.4-5.5; P = .003) and simultaneous aortic branch revascularization (odds ratio: 2.7, 95% confidence interval: 1.3-5.4; P = .008).

CONCLUSIONS

In this study, the technical success rates of the percutaneous techniques demonstrated their feasibility during TEVAR. However, the number of access site complications for percutaneous techniques was higher compared with open approach, although the difference was not statistically significant. In the lack of evidence, the safety of the new MANTA plug-based vascular closure for TEVAR warrants further investigation.

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Naoum I, Eitan A, Galili O, Hayeq H, Shiran A, Zissman K, Sliman H, Jaffe R. Strategy for Totally Percutaneous Management of Vascular Injury in Combined Transfemoral Transcatheter Aortic Valve Replacement and Endovascular Aortic Aneurysm Repair Procedures. Am J Cardiol 2023;207:130-136. [PMID: 37738782 DOI: 10.1016/j.amjcard.2023.08.148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/25/2023] [Revised: 08/21/2023] [Accepted: 08/21/2023] [Indexed: 09/24/2023]

Gurkan S, Gur O, Sahin A, Donbaloglu M. The impact of obesity on perioperative and postoperative outcomes after elective endovascular abdominal aortic aneurysm repair. Vascular 2023;31:211-218. [PMID: 34932414 DOI: 10.1177/17085381211063316] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]

Abstract

BACKGROUND

Obesity is a common and growing health problem in vascular surgery patients, as it is in all patient groups. Evidence regarding body mass index (BMI) on endovascular aneurysm repair (EVAR) outcomes is not clear in the literature. We aimed to determine the impact of obesity on perioperative and midterm outcomes of elective EVAR between obese and non-obese patients.

METHODS

Under a retrospective study design, a total of 120 patients (109 males, 11 females, mean age: 74.45 ± 8.59 (53-92 years)) undergoing elective EVAR between June 2012 and May 2020 were reviewed. Patients were stratified into two groups: obese (defined as a body mass index (BMI) ≥ 30 kg/m²) and non-obese (mean BMI < 30 kg/m² (32.25 ± 1.07 kg/m² vs 25.85 ± 2.69 kg/m²)).

RESULTS

Of the 120 patients included in the study, 81 (67.5%) were defined as "nonobese," while 39 (32.5%) were obese. The mean BMI of the study group was 27.93 ± 3.78 kg/m². In obese patients, the procedure time, fluoroscopy time, and dose area product (DAP) values were longer than those of non-obese patients: 89.74 ± 20.54 vs 79.69 ± 28.77 min (p = 0.035), 33.23 ± 10.14 vs 38.17 ± 8.61 min (p = 0.01) and 133.69 ± 58.17 vs 232.56 ± 51.87 Gy.cm² (p < 0.001). Although there was no difference in sac shrinkage at 12-month follow-up, there was a significant decrease at 6-month follow-up in both groups (p = 0.017). Endoleak occurred in 17.9% (n = 7) of the obese group versus 11.1% (n = 9) of the non-obese group (p = 0.302). Iliac branch occlusion developed in four patients, 3 (3.7%) in the non-obese group and 1 (2.6%) in the obese group (p = 0.608). The all-cause mortality rate was slightly higher in the obese group; however, it did not differ between the groups (p = 0.463).

CONCLUSION

In addition to the longer procedure times, fluoroscopy times, and DAP values in obese patients, regardless of obesity, significant sac shrinkage in the first 6 months of follow-up was observed in both groups. No difference was documented with regards to mortality or morbidity following EVAR.

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Wang Q, Wu J, Ma Y, Zhu Y, Song X, Xie S, Liang F, Gimzewska M, Li M, Yao L. Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair. Cochrane Database Syst Rev 2023;1:CD010185. [PMID: 36629152 PMCID: PMC9832535 DOI: 10.1002/14651858.cd010185.pub4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/12/2023]

Abstract

BACKGROUND

Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. Therefore, it is critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. Endovascular abdominal aortic aneurysm repairs (EVARs) are now a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft is introduced to the aneurysm in this way. This Cochrane Review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. However, the technique may be less applicable in people with, for example, groin scarring or arterial calcification. This is an update of the previous Cochrane Review published in 2017.

OBJECTIVES

To evaluate the benefits and harms of totally percutaneous access compared to cut-down femoral artery access in people undergoing elective bifurcated abdominal endovascular aneurysm repair (EVAR).

SEARCH METHODS

We used standard, extensive Cochrane search methods The latest search was 8 April 2022.

SELECTION CRITERIA

We included randomised controlled trials in people diagnosed with an AAA comparing totally percutaneous versus surgical cut-down access endovascular repair. We considered all device types. We only considered studies investigating elective repairs. We excluded studies reporting emergency surgery for ruptured AAAs and those reporting aorto-uni-iliac repairs.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methods. Our primary outcomes were 1. short-term mortality, 2. failure of aneurysm exclusion and 3. wound infection. Secondary outcomes were 4. major complications (30-day or in-hospital); 5. medium- to long-term (6 and 12 months) complications and mortality; 6. bleeding complications and haematoma; and 7. operating time, duration of intensive treatment unit (ITU) stay and hospital stay. We used GRADE to assess the certainty of evidence for the seven most clinically relevant primary and secondary outcomes.

MAIN RESULTS

Three studies with 318 participants met the inclusion criteria, 189 undergoing the percutaneous technique and 129 treated by cut-down femoral artery access. One study had a small sample size and did not adequately report the method of randomisation, allocation concealment or preselected outcomes. The other two larger studies had few sources of bias and good methodology; although one study had a high risk of bias in selective reporting. We observed no clear difference in short-term mortality between groups, with only one death occurring overall, in the totally percutaneous group (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.06 to 36.18; 2 studies, 181 participants; low-certainty evidence). One study reported failure of aneurysm exclusion. There was one failure of aneurysm exclusion in the surgical cut-down femoral artery access group (RR 0.17, 95% CI 0.01 to 4.02; 1 study, 151 participants; moderate-certainty evidence). For wound infection, there was no clear difference between groups (RR 0.18, 95% CI 0.01 to 3.59; 3 studies, 318 participants; moderate-certainty evidence). There was no clear difference between percutaneous and cut-down femoral artery access groups in major complications (RR 1.21, 95% CI 0.61 to 2.41; 3 studies, 318 participants; moderate-certainty evidence), bleeding complications (RR 1.02, 95% CI 0.29 to 3.64; 2 studies, 181 participants; moderate-certainty evidence) or haematoma (RR 0.88, 95% CI 0.13 to 6.05; 2 studies, 288 participants). One study reported medium- to long-term complications at six months, with no clear differences between the percutaneous and cut-down femoral artery access groups (RR 0.82, 95% CI 0.25 to 2.65; 1 study, 135 participants; moderate-certainty evidence). We detected differences in operating time, with the percutaneous approach being faster than cut-down femoral artery access (mean difference (MD) -21.13 minutes, 95% CI -41.74 to -0.53 minutes; 3 studies, 318 participants; low-certainty evidence). One study reported the duration of ITU stay and hospital stay, with no clear difference between groups.

AUTHORS' CONCLUSIONS

Skin puncture may make little to no difference to short-term mortality. There is probably little or no difference in failure of aneurysm exclusion (failure to seal the aneurysms), wound infection, major complications within 30 days or while in hospital, medium- to long-term (six months) complications and bleeding complications between the two groups. Compared with exposing the femoral artery, skin puncture may reduce the operating time slightly. We downgraded the certainty of the evidence to moderate and low as a result of imprecision due to the small number of participants, low event rates and wide CIs, and inconsistency due to clinical heterogeneity. As the number of included studies was limited, further research into this technique would be beneficial.

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Lee J, Huh U, Song S, Lee CW. Acute limb ischemia after minimally invasive cardiac surgery using the ProGlide: A case series. World J Clin Cases 2022;10:13052-13057. [PMID: 36569024 PMCID: PMC9782955 DOI: 10.12998/wjcc.v10.i35.13052] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/30/2022] [Revised: 10/12/2022] [Accepted: 11/17/2022] [Indexed: 12/14/2022] Open

Akbulut M, Ak A, Arslan Ö, Akardere ÖF, Karakoç AZ, Gume S, Şişmanoğlu M, Tuncer MA. Comparison of percutaneous access and open femoral cutdown in elective endovascular aortic repair of abdominal aortic aneurysms. TURK GOGUS KALP DAMAR CERRAHISI DERGISI 2022;30:11-17. [PMID: 35444858 PMCID: PMC8990152 DOI: 10.5606/tgkdc.dergisi.2022.21898] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 04/05/2021] [Accepted: 11/09/2021] [Indexed: 06/14/2023]

Mathisen SR, Nilsson KF, Larzon T. A Single Center Study of ProGlide Used for Closure of Large-Bore Puncture Holes After EVAR for AAA. Vasc Endovascular Surg 2021;55:798-803. [PMID: 34105422 DOI: 10.1177/15385744211022654] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]

Abstract

PURPOSE

The objective of this study was to evaluate the primary and assisted secondary percutaneous and non-invasive technical success of the ProGlide device on all-comers in a consecutive case series of percutaneous endovascular aortic aneurysm repair (P-EVAR).

METHOD

A single-center consecutive case series where 434 elective and acute P-EVAR procedures were registered prospectively between May 2011 and July 2017. The mean age was 74.5 years ± SD 11.4 years. 82.3% of the patients were male. All patients were pre-planned from CT angiography. Percutaneous access punctures, performed in local anesthesia in the common femoral artery, with a final introducer size between 12-22 Fr OD were included and stratified in 2 groups, 12-16 Fr and 17-22 Fr.

RESULTS

By screening 868 access groins 22 groins were excluded. Of the remaining 846 groins, intended to be treated with ProGlide, 9 groins were excluded peri-procedurally and treated with the Fascia Suture Technique or surgical cutdown. The remaining 837 groins had access closure with ProGlide, with a mean value of 2.15 devices per groin with a slight significant difference between the 2 stratification groups. Primary ProGlide technical success was achieved in 68.1% of the groins. Secondary percutaneous or non-invasive technical success was achieved in 96.9%. Here there was no statistically significant difference between the 2 stratification groups. Thirty-one (3.7%) groin complications were registered during 30-day follow-up and 17 required additional treatment. Total mortality was 2.8%. None of these deaths were related to the access site.

CONCLUSION

ProGlide by itself has a significant failure rate in the closure of large-bore access holes on an unselected cohort of patients eligible for P-EVAR. However, together with adjunct percutaneous or non-invasive methods a success rate of 97% can be achieved. The access complication rate was lower than 4% at 30-day follow-up.

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Taher F, Plimon M, Isaak A, Falkensammer J, Pablik E, Walter C, Kliewer M, Assadian A. Ultrasound-Guided Percutaneous Arterial Puncture and Closure Device Training in a Pulsatile Model. JOURNAL OF SURGICAL EDUCATION 2020;77:1271-1278. [PMID: 32205111 DOI: 10.1016/j.jsurg.2020.02.032] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/21/2019] [Revised: 01/20/2020] [Accepted: 02/29/2020] [Indexed: 06/10/2023]

Abstract

OBJECTIVE

The current study assesses the feasibility of in vitro practice of percutaneous puncture techniques in a pulsatile flow-model.

DESIGN

Prospective, controlled, randomized study.

SETTING

The percutaneous access to endovascular aortic repair is considered safe, but success rates may be dependent on surgeon experience with the technique.

PARTICIPANTS

Fourteen vascular surgery trainees and consultants were enrolled and randomized to a study or control group with both groups receiving instructions by a tutor on how to perform ultrasound guided percutaneous puncture and closure using a suture-mediated closure device. The study group received additional hands-on training on a pulsatile flowmodel of the groin and the performance of both groups was then graded. Study group participants were timed during and after their training on the model.

RESULTS

The study group achieved higher overall grading than the control group on a 5-point scale with higher scores indicating a better performance (mean overall scores 4.0 ± 0.7 versus 2.8 ± 1.0, respectively; p = 0.03). Experienced participants (more than 20 punctures performed before the study) achieved higher overall scores than trainees (3.8 ± 0.4 versus 2.5 ± 0.8, respectively; p = 0.01). Five participants in the study group could deploy and close the ProGlide closure device correctly without the help of a tutor while being graded (71% in the study versus 0% in the control group; p = 0.02). Study group participants improved their overall score from 3.2 ± 0.9 to 4.0 ± 0.7 during training (p = 0.02). Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001).

CONCLUSIONS

Study group participants could improve their overall score while working on the simulator. More experienced participants performed better during the simulation, which may indicate the model to be life-like and a potential skills assessment tool. Simulation training may be a valuable adjunct to traditional forms of training when teaching an endovascular technique but is limited by its reliance on simulators and demo devices.

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Kaur N, Sihag BK, Panda P, Naganur S, Barwad P. Large arteriotomies closure using a combination of vascular closure devices during TEVAR/EVAR: A single centre experience. Indian Heart J 2020;72:293-295. [PMID: 32861386 PMCID: PMC7474102 DOI: 10.1016/j.ihj.2020.06.008] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/26/2020] [Revised: 05/29/2020] [Accepted: 06/21/2020] [Indexed: 12/17/2022] Open

Çelik Ö, Şahin AA, Güner A, Demir AR, Uzun N, Ertürk M. Clinical efficacy and safety of the PRO-glide device as a sUture-mediated ClosurE in Thoracic EndoVascular Aortic Repair in patients with previous groin intervention (from the PRODUCE-TEVAR Trial). Vascular 2020;29:237-243. [PMID: 32829695 DOI: 10.1177/1708538120949669] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]

Abstract

BACKGROUND

While the percutaneous approach is increasingly preferred, suture-mediated closure devices have been put into clinical practice to close the femoral artery during procedures requiring a large-sized introducer. However, scar in the groin is considered a contraindication or an exclusion criterion for percutaneous procedures. The aim of our study was to investigate the outcomes and safety of Pro-Glide device as suture-mediated closure device in patients who underwent thoracic endovascular aortic repair with percutaneous femoral access ≥22 F who had previous groin intervention.

METHODS

A total of 73 patients who underwent endovascular repair with percutaneous femoral access were retrospectively included in the study. Previous groin intervention was defined as history of open surgical access or large sheath insertion (>18 F) to femoral artery because of endovascular or valvular intervention. Patients were divided into two groups as who had previous groin intervention PGI (+) and had not PGI (-).

RESULTS

A total of 73 patients [60 male (82.2%)] were included in the study. Seventeen patients had PGI, and 56 did not. When groups were compared in terms of sheath sizes, a significantly higher sheath sizes were used in PGI (+) patients (24.5 ± 1.1 F vs. 23.8 ± 0.9 F, p = 0.005). The overall success rate in the femoral approach with pre-close technique was statistically insignificant between two groups (94.1% vs. 96.4%, p = 0.55). One patient in PGI (+) group and two patients in PGI (-) had technical failure for percutaneous femoral approach. One patient (5.9%) in PGI (+) group and one patient (1.8%) in PGI (-) group had femoral complications after the procedures; however, there was no significant difference between the groups in terms of complications (5.9% vs. 1.8%, p = 0.13).

CONCLUSION

Pro-Glide device may be a safe and less invasive method for femoral access in patients with PGI and might not be considered as a contraindication for patients with history of PGI.

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Gao H, Luo M, Fang K, Fan B, Zhao J, Xue Y, Shu C. Cumulative sum analysis of the learning curve for the preclosure technique using Proglide. Interact Cardiovasc Thorac Surg 2020;30:280-286. [PMID: 31665309 DOI: 10.1093/icvts/ivz257] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/19/2019] [Revised: 09/23/2019] [Accepted: 09/29/2019] [Indexed: 12/17/2022] Open

Abstract

OBJECTIVES

Our study aims to assess the technical quality and the learning curve of the preclosure technique for a vascular surgeon using Proglide using cumulative sum analysis (CUSUM analysis).

METHODS

This study was designed retrospectively and enrolled 81 consecutive patients with 88 access sites who underwent endovascular aortic repair or thoracic endovascular aortic repair with the preclosure technique using Proglide between July 2017 and February 2018. The patients were divided into 2 groups chronologically: (A) the first 40 cases and (B) the latter 41 cases. Logistic regression analysis was used to assess the impact of technical risk factors on the success of the preclosure technique, and the χ2 test and 1-way ANOVA were applied to analyse the distribution of individual characteristics and risk factors between the 2 groups. CUSUM analysis was adapted to analyse the learning curve and to monitor the technical quality, with a predetermined target failure rate of 5%, an alternative failure rate of 20% and calculated 80% 'alert', 95% 'alarm' and 80% 'reassurance' lines.

RESULTS

Primary technical success was obtained in 81 (92.05%) access sites. There were no significant correlations between primary technical success and risk factors, including, common femoral artery diameter (P = 0.88), common femoral artery depth from the skin (P =0.94), the level of common femoral artery calcification (P =0.86) and size of sheath (P =0.96). Moreover, the distribution of related risk factors was not significantly different between groups A and B. CUSUM analysis showed that the cumulative failure rate never crossed the 80% 'alert' and 95% 'alarm' lines. Additionally, the failure rate began to approach the 80% 'reassurance' line after ∼22 cases and crossed the 80% 'reassurance' line after 36 cases.

CONCLUSIONS

The technique of totally percutaneous access using Proglide is safe and effective for an experienced vascular surgeon, even if the operator has no previous experience with any preclosure techniques. CUSUM analysis showed that 36 cases are necessary to achieve the target failure rate of 5%.

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Meertens M, Laturnus J, Ling A, Atkinson N, Mees B, Wagner T. Percutaneous Axillary Artery Access in Complex Endovascular Aortic Repair. J Vasc Interv Radiol 2019;30:830-835. [DOI: 10.1016/j.jvir.2018.12.735] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/09/2018] [Revised: 12/31/2018] [Accepted: 12/31/2018] [Indexed: 12/17/2022] Open

Trinidad B, Rybin D, Doros G, Eslami M, Tan TW. Factors Associated with Wound Complications after Open Femoral Artery Exposure for Elective Endovascular Abdominal Aortic Aneurysm Repair. Int J Angiol 2019;28:124-129. [PMID: 31384110 DOI: 10.1055/s-0039-1683898] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022] Open

Liang P, O'Donnell TFX, Swerdlow NJ, Li C, Lee A, Wyers MC, Hamdan AD, Schermerhorn ML. Preoperative risk score for access site failure in ultrasound-guided percutaneous aortic procedures. J Vasc Surg 2019;70:1254-1262.e1. [PMID: 30852039 DOI: 10.1016/j.jvs.2018.12.025] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2018] [Accepted: 12/12/2018] [Indexed: 12/17/2022]

Abstract

OBJECTIVE

The factors associated with access site failure after ultrasound-guided percutaneous access for aortic endograft procedures remain poorly characterized. We developed a prediction model to risk stratify patients for access site failure.

METHODS

We performed a retrospective institutional review of consecutive patients who underwent endovascular aneurysm repair (EVAR), fenestrated EVAR (FEVAR), or thoracic endovascular aortic repair (TEVAR) from 2014 to 2016. We excluded patients undergoing direct aortic access through sternotomy and patients treated with physician-modified endografts, given reporting restrictions. Our primary outcome was groin access site failure, which included bleeding and thrombosis. An 8-point risk model was created for access site failure using multivariable fractional polynomials and internally validated using bootstrapping.

RESULTS

We identified 469 femoral arteries from 247 patients undergoing endovascular aortic repair procedures (EVAR, 75%; FEVAR, 8.0%; TEVAR, 17%). Surgeons performed percutaneous access in 97.2% of the femoral arteries, with 99.6% ultrasound use. Twenty-seven (5.9%) access site failures occurred (17 bleeding, 10 thrombosis), all treated with groin cutdown, for a successful percutaneous femoral artery access rate of 94%. Of the 215 patients with attempted bilateral percutaneous access, 90% had successful bilateral access. However, FEVAR had lower rates of successful bilateral access (FEVAR, 78%; EVAR, 91%; TEVAR, 94%; P = .03). Factors independently associated with percutaneous access site failure were femoral artery outer wall diameter (per millimeter increase: odds ratio [OR], 0.003 [0.0002-0.1]; P < .001), femoral artery stenosis >50% (OR, 22.3 [2.7-183.2]; P < .01), and urgent/emergent intervention (OR, 3.6 [1.2-11.0]; P = .03). A risk prediction model based on these criteria produced a C statistic of 0.89, a Hosmer-Lemeshow goodness of fit of 0.99, and a Brier score of 0.04. Excluding treatment for ruptured aneurysms, cutdown for access failure and planned initial groin cutdown resulted in longer postoperative lengths of stay and higher rates of access-related readmission, return to operating room, groin infection, and myocardial infarction compared with successful percutaneous access. There was no difference in major adverse events between planned initial groin cutdown and cutdown after failure; however, the small number of patients in these two comparison groups limits the statistical power to detect a difference.

CONCLUSIONS

Percutaneous ultrasound-guided access can be safely performed in almost all patients undergoing endovascular aortic procedures, but access site failures do occur. This risk score can help users select patients with high likelihood of success, identify patients who need close scrutiny with postclosure femoral duplex ultrasound, and provide patient guidance about risk of unplanned groin cutdown.

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Maeda K, Ohki T, Kanaoka Y, Baba T, Shukuzawa K, Takizawa R, Omori M. A new option using adjunctive microsheath angiography to increase the safety during percutaneous endovascular aortic aneurysm repair. THE JOURNAL OF CARDIOVASCULAR SURGERY 2018;61:78-83. [PMID: 30168307 DOI: 10.23736/s0021-9509.18.10595-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]

Abstract

BACKGROUND

Percutaneous endovascular aortic repair (PEVAR) is widespread for the treatment of abdominal aortic aneurysm (AAA). The purpose of this study was to present outcomes of PEVAR using simultaneous angiography via microsheath.

METHODS

There were 100 punctures in 50 patients undergoing PEVAR for AAA. All cases used the ProGlide closure device (Abbot Vascular, Santa Clara, CA, USA) for PEVAR, and another puncture with microsheath placed on the common femoral artery for a second insertion point of the ProGlide. Basically, a single ProGlide was used for each puncture in the PEVAR. Hemostasis, stenosis, dissection, and distal embolization were confirmed in angiography via the adjunctive microsheath after removal of the delivery system. Since the PEVAR for AAA requires at least two punctures, this procedure was applied to both sites. Primary outcome was technical success and occurrence rates of access-related complications in PEVAR. Technical success was defined as complete hemostasis without surgical intervention and the need for conversion to general anesthesia.

RESULTS

Technical success was achieved in 98% (98/100) of the cases. Access-related complications on perioperative periods were identified in two cases. One case involved a tip of the microsheath being transected by the ProGlide that led to a distal embolization, which is why a cut down was required to retrieve the tip of the sheath. Another case required a cut down due to persistent hemorrhage from the puncture site of the microsheath. Although persistent hemorrhage was identified in five punctures (5.0%) via the adjunctive microsheath angiography, additional manual compression or ProGlide achieved complete hemostasis. Both stenosis and dissection following PEVAR were not identified in any case.

CONCLUSIONS

A supporting angiography via microsheath in confirming the absence of hemorrhage, stenosis, dissection, and distal embolization may be worthwhile to selectively use for cases of PEVAR.

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Karaolanis G, Kostakis ID, Moris D, Palla VV, Moulakakis KG. Fascia Suture Technique and Suture-mediated Closure Devices: Systematic Review. Int J Angiol 2018;27:13-22. [PMID: 29483761 PMCID: PMC5825226 DOI: 10.1055/s-0037-1620241] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022] Open

Ong DY, Tan GWL, Chan MSL, Pua U. Common Femoral Artery Caliber Changes after Percutaneous versus Surgical Access in Endovascular Aneurysm Repair in the Asian Population. Ann Vasc Surg 2017;47:266-271. [PMID: 28943488 DOI: 10.1016/j.avsg.2017.09.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/02/2017] [Revised: 07/23/2017] [Accepted: 09/18/2017] [Indexed: 10/18/2022]

Agrusa CJ, Meltzer AJ, Schneider DB, Connolly PH. Safety and Effectiveness of a “Percutaneous-First” Approach to Endovascular Aortic Aneurysm Repair. Ann Vasc Surg 2017;43:79-84. [DOI: 10.1016/j.avsg.2017.02.004] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2016] [Revised: 01/24/2017] [Accepted: 02/07/2017] [Indexed: 12/17/2022]

A Retrospective Analysis of Surgical Femoral Artery Closure Techniques: Conventional versus Purse Suture Technique. Ann Vasc Surg 2017;44:103-112. [PMID: 28483631 DOI: 10.1016/j.avsg.2017.04.032] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/02/2016] [Revised: 04/13/2017] [Accepted: 04/14/2017] [Indexed: 12/17/2022]

Abstract

BACKGROUND

Different techniques have been reported for the exploration and repair of femoral artery (FA) in patients who undergo minimally invasive cardiac surgery (MICS) and endovascular aortic surgery. We used a modified approach alternative to the conventional technique (group CT) since May 2013, which specifies a shorter groin incision and diamond-shaped hemostatic purse sutures for arteriotomy closure without the requirement of cross-clamping (group PT [purse suture technique]) and evaluated early outcomes and the complication profiles of the 2 techniques for femoral access.

METHODS

In our clinic, between May 2011 and December 2015, 503 FA cannulations were performed on 345 patients who underwent MICS (n = 109, mean age 64.1 ± 17.6 years, female/male ratio 71/38), endovascular abdominal aneurysm repair (n = 158, mean age 71.3 ± 10.2 years, female/male ratio 63/95), thoracal endovascular aneurysm repair (n = 50, mean age 65.0 ± 15.3 years, female/male ratio 15/35), and transaortic valve implantation (n = 28, mean age 80.8 ± 5.9 years, female/male ratio 13/15). A total of 295 FAs were exposed via mini incision and were repaired with the PT. We compared the duration of femoral closure (FC), wound infection, and vascular complications including bleeding hematoma, thromboembolic and ischemic events, pseudoaneurysm, seroma, surgical reintervention rates, delayed hospital stay for groin complications, and existence of postoperative local luminal narrowing (LLN) at the intervention site over 25% for both groups.

RESULTS

FC time (CT 14.9 ± 3.16 min, PT 6.5 ± 1.12 min, P < 0.0001), bleeding hematoma frequency (CT 6.2%, PT 1.7%, P = 0.01), and prolonged hospital stay for groin complications (CT 14.9%, PT 3.4%, P < 0.0001) were significantly lower in the PT group. Rate of technical success (CT 80.3%, PT 87.4%, P = 0.03) and event-free patient (CT 66.1%, PT 77.5%, P = 0.03) were significantly better in the PT group. There were no differences between groups in terms of ischemic events, wound infection rates, development of pseudoaneurysm and seroma, surgical reintervention rates, and LLN of FA over 25% at 6-month duplex evaluation.

CONCLUSIONS

The comparison of the 2 approaches revealed the advantages of the PT in terms of bleeding hematoma and shortening in FC time and the length of hospital stay. We suggest performing a smaller skin incision for FA access and utilizing purse sutures, which allows completing the procedure without cross-clamping, thus providing a favorable approach and excellent comfort for the surgeon.

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Gimzewska M, Jackson AIR, Yeoh SE, Clarke M, Cochrane Vascular Group. Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair. Cochrane Database Syst Rev 2017;2:CD010185. [PMID: 28221665 PMCID: PMC6464496 DOI: 10.1002/14651858.cd010185.pub3] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]

Abstract

BACKGROUND

Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. It is, therefore, critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. Endovascular abdominal aortic aneurysm repairs (EVARs) are now a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft introduced to the aneurysm in this way. This review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. The technique may, however, be less applicable in people with, for example, groin scarring or arterial calcification. This is an update of the review first published in 2014.

OBJECTIVES

This review aims to compare the clinical outcomes of percutaneous access with surgical cut-down femoral artery access in elective bifurcated abdominal endovascular aneurysm repair (EVAR).

SEARCH METHODS

For this update the Cochrane Vascular Information Specialist (CIS) searched their Specialised Register (last searched October 2016) and CENTRAL (2016, Issue 9). We also searched clinical trials registries and checked the reference lists of relevant retrieved articles.

SELECTION CRITERIA

We considered only randomised controlled trials. The primary intervention was a totally percutaneous endovascular repair. We considered all device types. We compared this against surgical cut-down femoral artery access endovascular repair. We only considered studies investigating elective repairs. We excluded studies reporting emergency surgery for a ruptured abdominal aortic aneurysm and those reporting aorto-uni-iliac repairs.

DATA COLLECTION AND ANALYSIS

Two review authors independently collected all data. Owing to the small number of trials identified we did not conduct any formal sensitivity analysis. Heterogeneity was not significant for any outcome.

MAIN RESULTS

Two studies with a total of 181 participants met the inclusion criteria, 116 undergoing the percutaneous technique and 65 treated by cut-down femoral artery access. One study had a small sample size and did not adequately report method of randomisation, allocation concealment or pre-selected outcomes. The second study was a larger study with few sources of bias and good methodology.We observed no significant difference in mortality between groups, with only one mortality occurring overall, in the totally percutaneous group (risk ratio (RR) 1.50; 95% confidence interval (CI) 0.06 to 36.18; 181 participants; moderate-quality evidence). Only one study reported aneurysm exclusion. In this study we observed only one failure of aneurysm exclusion in the surgical cut-down femoral artery access group (RR 0.17, 95% CI 0.01 to 4.02; 151 participants; moderate-quality evidence). No wound infections occurred in the cut-down femoral artery access group or the percutaneous group across either study (moderate-quality evidence).There was no difference in major complication rate between cut-down femoral artery access and percutaneous groups (RR 0.91, 95% CI 0.20 to 1.68; 181 participants; moderate-quality evidence); or in bleeding complications and haematoma (RR 0.94, 95% CI 0.31 to 2.82; 181 participants; high-quality evidence).Only one study reported long-term complication rates at six months, with no differences between the percutaneous and cut-down femoral artery access group (RR 1.03, 95% CI 0.34 to 3.15; 134 participants; moderate-quality evidence).We detected differences in surgery time, with percutaneous approach being significantly faster than cut-down femoral artery access (mean difference (MD) -31.46 minutes; 95% CI -47.51 minutes to -15.42 minutes; 181 participants; moderate-quality evidence). Only one study reported duration of ITU (intensive treatment unit) and hospital stay, with no difference found between groups.

AUTHORS' CONCLUSIONS

This review shows moderate-quality evidence of no difference between the percutaneous approach compared with cut-down femoral artery access group for short-term mortality, aneurysm exclusion, major complications, wound infection and long-term (six month) complications, and high-quality evidence for no difference in bleeding complications and haematoma. There was a difference in operating time, with moderate-quality evidence showing that the percutaneous approach was faster than the cut-down femoral artery access technique. We downgraded the quality of the evidence to moderate as a result of the limited number of studies, low event numbers and imprecision. As the number of included studies were limited, further research into this technique would be beneficial. The search identified one ongoing study, which may provide an improved evidence base in the future.

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Li J, Tian X, Wang Z, Xiong J, Fan Y, Deng X, Sun A, Liu X. Influence of endoleak positions on the pressure shielding ability of stent-graft after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA). Biomed Eng Online 2016;15:135. [PMID: 28155691 PMCID: PMC5259942 DOI: 10.1186/s12938-016-0249-z] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022] Open

Hajibandeh S, Hajibandeh S, Antoniou SA, Child E, Torella F, Antoniou GA. Percutaneous access for endovascular aortic aneurysm repair: A systematic review and meta-analysis. Vascular 2016;24:638-648. [DOI: 10.1177/1708538116639201] [Citation(s) in RCA: 36] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]

Dosluoglu HH, Cherr GS, Harris LM, Dryjski ML. Total Percutaneous Endovascular Repair of Abdominal Aortic Aneurysms Using Perclose ProGlide Closure Devices. J Endovasc Ther 2016;14:184-8. [PMID: 17484534 DOI: 10.1177/152660280701400210] [Citation(s) in RCA: 59] [Impact Index Per Article: 6.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]

Ichihashi T, Ito T, Kinoshita Y, Suzuki T, Ohte N. Safety and utility of total percutaneous endovascular aortic repair with a single Perclose ProGlide closure device. J Vasc Surg 2016;63:585-8. [DOI: 10.1016/j.jvs.2015.08.111] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2015] [Accepted: 08/27/2015] [Indexed: 12/17/2022]

de Souza LR, Oderich GS, Banga PV, Hofer JM, Wigham JR, Cha S, Gloviczki P. Outcomes of total percutaneous endovascular aortic repair for thoracic, fenestrated, and branched endografts. J Vasc Surg 2015;62:1442-9.e3. [DOI: 10.1016/j.jvs.2015.07.072] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2015] [Accepted: 07/14/2015] [Indexed: 12/17/2022]

Totally Percutaneous Endovascular Aneurysm Repair Using the Preclosing Technique. Surg Laparosc Endosc Percutan Tech 2015;25:354-7. [DOI: 10.1097/sle.0000000000000176] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]

Aranson NJ, Watkins MT. Percutaneous interventions in aortic disease. Circulation 2015;131:1291-9. [PMID: 25847980 DOI: 10.1161/circulationaha.114.006512] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]

Morgan CE, Herm-Barabasz R, Rodriguez HE, Hoel AW, Eskandari MK. Incidence of acute lower extremity venous thrombosis after percutaneous endovascular aneurysm repair. J Vasc Surg 2015;62:351-4. [PMID: 25937605 DOI: 10.1016/j.jvs.2015.03.034] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2014] [Accepted: 03/15/2015] [Indexed: 12/17/2022]

Abstract

BACKGROUND

Improvements in endovascular aortic aneurysm repair (EVAR) have led many physicians to embrace a purely percutaneous approach using the suture-mediated "preclose" technique. Whereas there are a number of theoretical benefits, the rate of periprocedural iatrogenic acute deep venous thrombosis (DVT) is unknown. We sought to determine the incidence of acute DVT after percutaneous EVAR (PEVAR).

METHODS

This was a single-center, retrospective review of 52 consecutive patients undergoing elective PEVAR. Demographics, procedural data, and postprocedure lower extremity venous duplex ultrasound data were analyzed by univariate statistical analysis.

RESULTS

Among the 52 patients, the average age was 73 years, and the majority were men (n = 44). Only 6% (n = 3) had a prior history of DVT. The majority of procedures were performed under general anesthesia (n = 51 [98%]) with systemic intravenous heparin. Protamine was used in only 13 cases (25%). Sheath sizes ranged from 9F to 20F, with an average of 16F, and closure was achieved using the preclose technique. Postprocedure chemoprophylaxis was administered to 85% of patients (n = 44) during their hospitalization. Median length of stay was 1 day. Acute DVT was identified in 8% of patients (n = 4) on postoperative day 1. Among the 4 DVTs, 25% were femoropopliteal (n = 1) and 75% were calf vein DVTs (n = 3). On follow-up imaging 2 weeks later, 75% of DVTs were resolved. Among the four patients with acute DVT on postoperative day 1, three had associated risk factors: history of DVT (n = 2), active smokers (n = 1), and obesity (body mass index >30; n = 3). The remaining patient had no risk factors but developed an ipsilateral calf vein DVT.

CONCLUSIONS

The risk of acute DVT after PEVAR is low. Lower extremity venous duplex ultrasound screening is not necessary unless there exist preclinical risk factors or postprocedural clinical indications suggestive of DVT.

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Geis NA, Pleger ST, Chorianopoulos E, Müller OJ, Katus HA, Bekeredjian R. Feasibility and clinical benefit of a suture-mediated closure device for femoral vein access after percutaneous edge-to-edge mitral valve repair. EUROINTERVENTION 2015;10:1346-53. [PMID: 24694560 DOI: 10.4244/eijv10i11a231] [Citation(s) in RCA: 38] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]

Larzon T, Roos H, Gruber G, Henrikson O, Magnuson A, Falkenberg M, Lönn L, Norgren L. Editor's Choice - 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. [DOI: 10.1016/j.ejvs.2014.10.021] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/02/2014] [Accepted: 10/03/2014] [Indexed: 12/17/2022]

Petronelli S, Zurlo MT, Giambersio S, Danieli L, Occhipinti M. A single-centre experience of 200 consecutive unselected patients in percutaneous EVAR. Radiol Med 2014;119:835-41. [PMID: 24700151 DOI: 10.1007/s11547-014-0399-7] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2013] [Accepted: 11/22/2013] [Indexed: 12/17/2022]

Jackson A, Yeoh SE, Clarke M. Totally percutaneous versus standard femoral artery access for elective bifurcated abdominal endovascular aneurysm repair. Cochrane Database Syst Rev 2014:CD010185. [PMID: 24578199 DOI: 10.1002/14651858.cd010185.pub2] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]

Abstract

BACKGROUND

Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. It is, therefore, critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. More recently endovascular aneurysm repairs (EVARs) have become a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft is introduced to the aneurysm in this way. This review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. The technique may, however, be less applicable in patients with, for example, groin scarring or arterial calcification.

OBJECTIVES

This review aims to compare the clinical outcomes of percutaneous access with standard femoral artery access in elective bifurcated abdominal endovascular aneurysm repair (EVAR).

SEARCH METHODS

The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched their Specialised Register (last searched July 2013), CENTRAL (2013, Issue 6) and clinical trials databases. Reference lists of retrieved articles were checked.

SELECTION CRITERIA

Only randomised controlled trials were considered. The primary intervention was a totally percutaneous endovascular repair. All device types were considered. This was compared against standard femoral artery endovascular repair. Only studies investigating elective repairs were considered. Studies reporting emergency surgery for a ruptured abdominal aortic aneurysm (rAAA) and those reporting aorto-uni-iliac repairs were excluded.

DATA COLLECTION AND ANALYSIS

All data were collected independently by two review authors. Owing to the small number of trials identified, no formal assessment of heterogeneity or sensitivity analysis was conducted.

MAIN RESULTS

Only one trial met the inclusion criteria, involving a total of 30 participants, 15 undergoing the percutaneous technique and 15 treated by the standard femoral cut-down approach. There were no significant differences between the two groups at baseline.No mortality or failure of aneurysm exclusion was observed in either group. Three wound infections occurred in the standard femoral cut-down group, whereas none were observed in the percutaneous group. This was not statistically significant. Only one major complication was observed in the study, a conversion to the cut-down technique in the percutaneous access group. No long-term outcomes were reported. One episode of a bleeding complication was reported in the percutaneous group. Significant differences were detected in surgery time (percutaneous 86.7 ± 27 minutes versus conventional 107.8 ± 38.5 minutes; P < 0.05).The included study had a small sample size and failed to report adequately the method of randomisation, allocation concealment and the pre-selected outcomes.

AUTHORS' CONCLUSIONS

Only one small study was identified, which did not provide adequate evidence to determine the efficacy and safety of the percutaneous approach compared with endovascular aneurysm repairs. This review has identified a clear need for further research into this potentially beneficial technique. One ongoing study was identified in the search, which may provide an improved evidence base in the future.

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Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. 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;59:1181-93. [PMID: 24440678 DOI: 10.1016/j.jvs.2013.10.101] [Citation(s) in RCA: 214] [Impact Index Per Article: 19.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2013] [Revised: 10/10/2013] [Accepted: 10/14/2013] [Indexed: 12/14/2022]

Abstract

OBJECTIVE

The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure.

METHODS

Between 2010 and 2012, 20 U.S. institutions participated in a prospective, Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a "preclose" technique in conjunction with endovascular abdominal aortic aneurysm repair. A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure (n = 101) or open femoral exposure (n = 50 [FE]). PEVAR procedures were performed with either the 8 F Perclose ProGlide (n = 50 [PG]) or the 10 F Prostar XL (n = 51 [PS]) closure devices. All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile (outer diameter) sheath-based system. Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access. The primary trial end point (treatment success) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days. An independent access closure substudy evaluated major access-related complications. Clinical utility and procedural outcomes, ankle-brachial index, blood laboratory analyses, and quality of life were also evaluated with continuing follow-up to 6 months.

RESULTS

Baseline characteristics were similar among groups. Procedural technical success was 94% (PG), 88% (PS), and 98% (FE). One-month primary treatment success was 88% (PG), 78% (PS), and 78% (FE), demonstrating noninferiority vs FE for PG (P = .004) but not for PS (P = .102). Failure rates in the access closure substudy analyses demonstrated noninferiority of PG (6%; P = .005), but not of PS (12%; P = .100), vs FE (10%). Compared with FE, PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss, groin pain, and overall quality of life. Initial noninferiority test results persist to 6 months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred.

CONCLUSIONS

Among trained operators, PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective, with minimal access-related complications, and it is noninferior to standard open femoral exposure. Training, experience, and careful application of the preclose technique are of paramount importance in ensuring successful, sustainable outcomes.

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Percutaneous Closure of Large Femoral Artery Access with Prostar XL in Thoracic Endovascular Aortic Repair. Eur J Vasc Endovasc Surg 2013;46:558-63. [DOI: 10.1016/j.ejvs.2013.08.009] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2013] [Accepted: 08/18/2013] [Indexed: 12/17/2022]

Manunga JM, Gloviczki P, Oderich GS, Kalra M, Duncan AA, Fleming MD, Bower TC. Femoral artery calcification as a determinant of success for percutaneous access for endovascular abdominal aortic aneurysm repair. J Vasc Surg 2013;58:1208-12. [DOI: 10.1016/j.jvs.2013.05.028] [Citation(s) in RCA: 69] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2013] [Revised: 05/03/2013] [Accepted: 05/10/2013] [Indexed: 12/17/2022]

Kim WH, Shin S, Ko YG, Hong MK, Jang Y, Choi D. Efficacy and Safety of the Preclose Technique Following Percutaneous Aortic Stent-Graft Implantation. J Endovasc Ther 2013;20:350-5. [DOI: 10.1583/12-4103mr2.1] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/26/2022]

Stone PA, Campbell JE, Mousa AY, Aburahma AF. Basic data underlying clinical decision making in vascular surgery: arterial access for percutaneous procedures. Ann Vasc Surg 2013;27:379-88. [PMID: 23498311 DOI: 10.1016/j.avsg.2012.10.005] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2012] [Revised: 08/18/2012] [Accepted: 10/08/2012] [Indexed: 12/17/2022]

Jaffan AAA, Prince EA, Hampson CO, Murphy TP. The preclose technique in percutaneous endovascular aortic repair: a systematic literature review and meta-analysis. Cardiovasc Intervent Radiol 2013;36:567-77. [PMID: 23483284 DOI: 10.1007/s00270-013-0593-3] [Citation(s) in RCA: 39] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/07/2012] [Accepted: 02/12/2013] [Indexed: 12/17/2022]

Predicting the learning curve and failures of total percutaneous endovascular aortic aneurysm repair. J Vasc Surg 2013;57:72-6. [DOI: 10.1016/j.jvs.2012.07.050] [Citation(s) in RCA: 46] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2012] [Revised: 07/15/2012] [Accepted: 07/30/2012] [Indexed: 12/17/2022]

Hayashida K, Lefèvre T, Chevalier B, Hovasse T, Romano M, Garot P, Mylotte D, Uribe J, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Morice MC. True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device: impact of learning curve on vascular complications. JACC Cardiovasc Interv 2012;5:207-14. [PMID: 22361606 DOI: 10.1016/j.jcin.2011.09.020] [Citation(s) in RCA: 84] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2011] [Revised: 09/19/2011] [Accepted: 09/21/2011] [Indexed: 12/17/2022]

Abstract

OBJECTIVES

The purpose of this study was to evaluate the incidence of vascular complications and the predictors of Prostar failure for a "true percutaneous approach" in transfemoral transcatheter aortic valve implantation (TAVI).

BACKGROUND

Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort.

METHODS

Among 264 patients included in our prospective TAVI database (October 2006 to December 2010), transfemoral-TAVI was performed in 170 patients. True percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar was defined as adequate hemostasis without Prostar-related vascular complications. We compared the incidence of vascular complications in our early and late experience.

RESULTS

Patients were 83.0±7.2 years old and with a EuroSCORE of 24.0±11.6%. The Edwards valve (Edwards Lifesciences, Irvine, California) (18- to 24-F) was used in 109 cases and the CoreValve (Medtronic, Minneapolis, Minnesota) (18-F) in 31. The sheath outer diameter to minimal femoral diameter ratio (SFAR) was 0.96±0.14. Successful closure was achieved in 90.7%, and was significantly increased (95.7% vs. 85.7%, p=0.047) in the late experience group. Cross-over to surgery was required in 3.6%. Vascular complications occurred in 20.0%, and were significantly lower in the late experience group (11.4% vs. 28.6%, p=0.012). Major vascular complications (2.9% vs. 14.3%, p=0.018) were decreased in the late experience group. Early experience (hazard ratio [HR]: 3.66, 95% confidence interval [CI]: 1.04 to 13.89, p=0.047) and SFAR (HR: 110.80, 95% CI: 1.15 to 10,710.73, p=0.044) predicted Prostar failure by univariate analysis.

CONCLUSIONS

Experience reduced major vascular complications in a true percutaneous approach for transfemoral-TAVI. Further application of this less invasive strategy is feasible and may be beneficial, in this high-risk patient cohort.

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Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. JACC Cardiovasc Interv 2011;4:861-7. [PMID: 21851899 DOI: 10.1016/j.jcin.2011.05.019] [Citation(s) in RCA: 102] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/14/2011] [Revised: 04/11/2011] [Accepted: 05/25/2011] [Indexed: 12/12/2022]

Hayashida K, Lefèvre T, Chevalier B, Hovasse T, Romano M, Garot P, Mylotte D, Uribe J, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Morice MC. Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv 2011;4:851-8. [PMID: 21851897 DOI: 10.1016/j.jcin.2011.03.019] [Citation(s) in RCA: 425] [Impact Index Per Article: 30.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/14/2011] [Revised: 04/11/2011] [Accepted: 05/25/2011] [Indexed: 12/15/2022]

Abstract

OBJECTIVES

This study sought to evaluate the incidence, impact, and predictors of vascular complications in transcatheter aortic valve implantation (TAVI).

BACKGROUND

Vascular complications increase morbidity and mortality in transfemoral TAVI; however, there remains a paucity of data describing these serious events.

METHODS

We performed a prospective cohort study of 130 consecutive transfemoral TAVI recipients. Vascular complications were defined by the Valve Academic Research Consortium (VARC) criteria. The ratio of the sheath outer diameter (in millimeters) to the minimal femoral artery diameter (in millimeters) defined the sheath to femoral artery ratio (SFAR).

RESULTS

In our cohort of elderly patients (83.3 ± 5.9 years), the logistic EuroScore was 25.8% ± 11.9%. The Edwards valve was used in 102 cases (18- to 24-F) and the CoreValve in 27 (18-F). The minimal femoral artery diameter was 8.17 ± 1.14 mm, and the calcification (0 to 3) and tortuosity scores (0 to 3) were 0.58 ± 0.72 and 0.28 ± 0.53, respectively. The mean sheath diameter was 8.10 ± 0.82 mm, and the mean SFAR was 0.99 ± 0.16. Vascular complications occurred in 27.6% (VARC major: 17.3%, minor: 10.2%), and major vascular complications predicted 30-day mortality (22.7% vs. 7.6%, p = 0.049). The SFAR (hazard ratio [HR]: 186.20, 95% confidence interval [CI]: 4.41 to 7,855.11), center experience (HR: 3.66, 95% CI: 1.17 to 11.49), and femoral calcification (HR: 3.44, 95% CI: 1.16 to 10.17) predicted major complications by multivariate analysis. An SFAR threshold of 1.05 (area under the curve = 0.727) predicted a higher rate of VARC major complications (30.9% vs. 6.9%, p = 0.001) and 30-day mortality (18.2% vs. 4.2%, p = 0.016).

CONCLUSIONS

Vascular complications in transfemoral TAVI are relatively frequent. VARC major vascular complications increase 30-day mortality and are predicted by experience, femoral calcification, and SFAR. Routine application of SFAR will improve patient selection for transfemoral TAVI and may improve outcome.

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Montán C, Lehti L, Holst J, Björses K, Resch TA. Short- and Midterm Results of the Fascia Suture Technique for Closure of Femoral Artery Access Sites After Endovascular Aneurysm Repair. J Endovasc Ther 2011;18:789-96. [DOI: 10.1583/11-3621.1] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/14/2022]

Perdikides TP, Georgiadis GS, Avgerinos ED, Paraskevas KI, Siafakas KX, Katsargyris A, Fotis T, Lagios KG. Percutaneous endovascular treatment of aortic aneurysms: Clinical evaluation and literature results. MINIM INVASIV THER 2011;21:342-50. [DOI: 10.3109/13645706.2011.638642] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]

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. [DOI: 10.1583/11-342.1] [Citation(s) in RCA: 45] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/17/2022]

Arslan B, Turba UC, Sabri S, Angle JF, Matsumoto AH. Current status of percutaneous endografting. Semin Intervent Radiol 2011;26:67-73. [PMID: 21326533 DOI: 10.1055/s-0029-1208387] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]

Haulon S, Hassen Khodja R, Proudfoot C, Samuels E. A Systematic Literature Review of the Efficacy and Safety of the Prostar XL Device for the Closure of Large Femoral Arterial Access Sites in Patients Undergoing Percutaneous Endovascular Aortic Procedures. Eur J Vasc Endovasc Surg 2011;41:201-13. [DOI: 10.1016/j.ejvs.2010.10.015] [Citation(s) in RCA: 53] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2010] [Accepted: 10/26/2010] [Indexed: 12/17/2022]

Malkawi A, Hinchliffe R, Holt P, Loftus I, Thompson M. Percutaneous Access for Endovascular Aneurysm Repair: A Systematic Review. Eur J Vasc Endovasc Surg 2010;39:676-82. [DOI: 10.1016/j.ejvs.2010.02.001] [Citation(s) in RCA: 100] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2009] [Accepted: 02/01/2010] [Indexed: 12/17/2022]