Long-Term Evolution of Percutaneous Groin Access in Endovascular Aneurysm Repair: A Study of the Sequential Suture and Plug Vascular Closure Devices Technique

doi:10.21203/rs.3.rs-3927848/v1

Objective

This study aimed to assess the long-term complications and evolution of groin access using the sequential suture and plug vascular closure devices (VCDs) technique during endovascular aneurysm repair (EVAR).

Methods

We retrospectively reviewed data from all patients who underwent EVAR with more than 12 months of follow-up at our center between January 2022 and September 2022. The study included 64 patients with a mean age of 66.3 ± 13.9 years and a male-to-female ratio of 82.8%. We employed the sequential suture and plug VCDs technique as the standard practice for access closure. Technical success was defined as achieving complete hemostasis without needing bailout endovascular or surgical interventions. Access-related complications were assessed at 30 days and during the most recent follow-up computed tomography (CT) scan, with the severity graded according to the Society of Interventional Radiology (SIR) classification.

Results

The sequential suture and plug VCDs technique demonstrated a 100% success rate across the study population. The mean follow-up time from the procedure to the most recent scan was 16.1 ± 2.2 months, and the mean sheath size used was 20.5 ± 2.3 Fr. Short-term complications occurred in 4.1% of cases, comprising minor access bleeding incidents (n = 3) and pseudoaneurysm (n = 1). No long-term complications were observed during the study period, with no major complications reported. Additionally, the accessed vessels exhibited a significant increase in calcification score (1.02 ± 1.05 vs. 1.36 ± 1.08; p = 0.027) between the baseline and the last follow-up scan, while there were no significant changes in diameter.

Conclusions

The sequential suture and plug VCDs technique represents a safe method for access closure during EVAR, demonstrating low rates of short-term and long-term complications. However, further investigation through larger multi-center studies is warranted.

Health sciences/Diseases/Cardiovascular diseases/Vascular diseases

Health sciences/Cardiology/Interventional cardiology

Health sciences/Cardiology/Cardiovascular biology/Calcification

Endovascular aneurysm repair (EVAR) has gained widespread acceptance for treating aortic diseases in recent years, primarily owing to its lower post-procedure complications and faster recovery than open surgical repair^[1–3]. Traditionally, the procedure involved an open surgical femoral approach to accommodate the large stent graft system. However, with the advent of vessel closure devices (VCDs), percutaneous femoral access has become increasingly prevalent, offering advantages such as reduced hospitalization times and improved patient comfort^[3–5].

Nevertheless, access-related complications remain a pressing concern, as they are associated with a significantly elevated risk of morbidity and mortality^[6–7]. The double suture VCDs technique was conventionally employed for access closure, with reported complication rates ranging from 0–11.4%^{[5, 9–11]}. More recently, the suture and plug VCDs technique has emerged as an alternative option for access closure in procedures like transcatheter aortic valve implantation (TAVI) and EVAR^[12–13]. Several studies have suggested that this hybrid technique may lead to fewer vascular injuries while retaining the advantages of different VCDs^{[8, 10]}. However, data remains scarce regarding the long-term outcomes of EVAR groin access when utilizing the suture and plug VCDs technique. Specifically, there is limited follow-up data concerning long-term complications and the evolution of the access site, including changes in vessel diameter and calcification associated with this hybrid technique.

Thus, the primary objective of our study is to evaluate the long-term outcomes of EVAR groin access when employing the suture and plug VCDs technique, with a minimum follow-up period exceeding 12 months.

Patients

This retrospective cohort study encompassed all patients who underwent EVAR at our center between January 2022 and September 2022. Patients who underwent femoral access management using the sequential suture and plug VCDs technique were eligible for inclusion. Exclusion criteria comprised incomplete imaging studies, follow-up periods of less than 12 months, or mortality during the follow-up period. Figure 1 provides an overview of the study design. In total, 64 consecutive patients, accounting for 98 femoral access sites, were enrolled in this study. The mean age of the patients was 66.3 ± 13.9 years, with a male-to-female ratio of 82.8%. The patient characteristics are summarized in Table 1. Moreover, the institutional committee of our center approved this experiment including any relevant details. The research was performed in accordance with relevant guidelines and regulations, and the informed consent requirement was waived due to the retrospective and anonymous nature of the analysis.

Procedure details

Pre-procedure computed tomography (CT) angiography was conducted for all patients to evaluate the femoral access site and confirm its suitability for a completely percutaneous approach. Details regarding the anatomy of the access site are presented in Table 2. All procedures were performed under general, lumbar, or local anesthesia, and each patient received 100 U/kg of intravenous heparin. A small skin incision was made at the access site, and subcutaneous fat was dissected with mosquito forceps. Ultrasound-guided puncture was employed to confirm a vessel area free of calcification for guidewire advancement. Subsequently, one Proglide device was deployed at the 12 o'clock position. The EVAR procedure was carried out following standard protocols.

After the removal of the large-caliber sheath, Proglide (Abbott Vascular, Santa Clara, CA) sutures were tightened, and double Exoseal (Cordis, Milpitas, CA) devices were deployed to achieve hemostasis. The specific details of the current suture and plug VCDs technique have been previously reported, with the guidewire remaining in place until final hemostasis was confirmed. In summary, the orange component of the Exoseal devices was inserted to expose the indicator wire, which was then advanced with the Proglide sutures until the surgeon encountered resistance from the knot. After confirming the extra-vascular position of the Exoseal devices via ultrasound, the bioabsorbable polyglycolic acid (PGA) plug was released. In cases of excessive bleeding, an additional ProGlide device would be deployed through the guidewire to ensure hemostasis. Lastly, manual compression was applied multiple times before the hemostatic assessment. All access sites were immediately evaluated and assessed 24 hours post-procedure using ultrasound to detect complications.

Anticoagulation therapy (low molecular weight heparin sodium, 0.4 mL, twice a day) was recommended for all EVAR procedures, and antiplatelet therapy (clopidogrel 75 mg once a day) was prescribed for fenestrated or branched EVAR. Two main stent-graft systems were utilized: the Gore Excluder and CTAG (Gore, Newark, USA) and the Ankura (Lifetech Scientific, Shenzhen, China).

Definitions and follow-up

Procedural technical success was defined as achieving complete hemostasis without the need for surgical or endovascular intervention. Follow-up CT angiography was performed at 30 days and then every three months during the first year, followed by an annual protocol after the first year. Access site complications were classified as immediate, short-term, or long-term and included bleeding, infection, pseudoaneurysm, artery stenosis, dissection, extremity ischemia, and lymphocele. Short-term complications were assessed 30 days post-procedure, while long-term complications were assessed during the most recent follow-up scan. The severity of complications was graded according to the Society of Interventional Radiology (SIR) Adverse Event Classification^[14].

For CT imaging, artery depth was defined as the shortest distance in the puncture tract, and anterior wall artery calcification was considered present if it exceeded 2 mm. The artery calcification score was evaluated as previously reported^[15-16], with the following categories: 0 (no calcification), 1 (<33% calcification), 2 (33% to 66% calcification), and 3 (>66% calcification). Both the first and last post-operative CT scans were reviewed. The images were assessed by two radiologists with over five years of experience, and the average of their findings was recorded. Baseline data were obtained from online clinical records and standard operative records.

Statistical analysis

Continuous data were presented as mean ± standard deviation, and the t-test or Mann-Whitney U-test was used to assess differences when appropriate. Categorical data were expressed as numbers and percentages, with Pearson's chi-square test or Fisher's exact test applied as needed. All tests were two-tailed, and statistical significance was set at a P-value of <0.05. Statistical analyses were conducted using SPSS software (version 19.0; SPSS Inc., Chicago, IL, USA).

Clinical outcomes

Technical success was achieved in all patients (100%), and no unplanned endovascular or surgical interventions were required. Only two patients (2.0%) underwent additional Proglide device deployment. The mean follow-up duration was 16.1 ± 2.2 months (range 12 to 19 months), with a mean sheath size of 20.5 ± 2.3 Fr (range 16 to 24 Fr).

At the first post-procedure CT scan, three cases of minor access bleeding (SIR level 1) and one pseudoaneurysm (SIR level 2) were observed. There were no instances of extremity ischemia or major bleeding necessitating transfusion therapy. The minor bleeding cases were successfully resolved through manual compression, while the pseudoaneurysm was managed with a percutaneous thrombin injection. The short-term access-related complication rate was 4.1%. Importantly, during the last follow-up scan, no long-term complications were observed. The overall complication rate remained at 4.1%, and no major complications occurred during the study. The outcomes are summarized in Table 3.

Access site change

Changes in the diameter of the access vessels at the first and last post-procedure follow-ups were 8.23 ± 1.51 mm vs. 8.30 ± 1.53 mm and 8.26 ± 1.52 mm vs. 8.30 ± 1.53 mm, respectively (p = 0.751, p = 0.853). Similarly, changes in femoral artery depth were 3.13 ± 1.16 mm vs. 3.10 ± 1.17 mm and 3.08 ± 1.17 mm vs. 3.10 ± 1.17 mm, respectively (p = 0.852, p = 0.923).

Anterior wall calcification was observed in 14 cases (14.3%) at the first follow-up, which increased to 19 cases (19.4%) at the last follow-up. No significant differences were noted compared to the baseline (14.3% vs. 14.3%; 19.4% vs. 14.3%, p = 0.340). The access site calcification score remained comparable between the short-term group and the baseline (1.03 ± 1.04 vs. 1.02 ± 1.05, p = 0.945). However, it is noteworthy that the score significantly increased in the long-term group (1.36 ± 1.08 vs. 1.02 ± 1.05, p = 0.027). Figure 2 provides a visual representation of the access site changes.

In this retrospective, single-center study, we explored the long-term outcomes, including complications and changes in groin access, during EVAR using the suture and plug VCDs technique. Our findings revealed a short-term access-related complication rate of 4.1%, and notably, no long-term complications were observed within our cohort, which had a follow-up period exceeding 12 months. Overall, the suture and plug VCDs technique demonstrated a good safety profile for access closure during EVAR, characterized by low short-term and long-term complication rates. Nevertheless, the need for larger-scale studies to confirm these results remains essential.

Over the years, the suture and plug VCDs technique has emerged as a viable alternative for closing large-bore access during TAVI and EVAR^{[6, 8, 10, 12–13]}. However, prior studies predominantly focused on short-term variables such as technical success, length of hospital stay, and complications within 30 days post-procedure. The long-term evolution of access vessels and associated complications when employing the suture and plug VCDs technique has remained a less-explored area. In our investigation, we observed cases of minor bleeding (SIR level 1)(n = 3) and pseudoaneurysm (SIR level 2)(n = 1) at the first post-procedure follow-up. All patients experienced successful recovery without additional surgical or endovascular interventions. Additionally, at the last follow-up, no long-term complications were detected. Importantly, none of these complications were clinically significant or necessitated further treatment.

Furthermore, our study found no significant alteration in access vessel diameter between the first and last follow-up scans, suggesting the long-term patency of the access vessel and the absence of any progressive narrowing. Gmeiner^[8] et al. suggested that compared to the standard double Proglide technique, the suture and plug VCDs technique imposes less cinching and strain on the arterial wall. Ko^[10] et al. reported a higher incidence of arterial strictures in patients treated with multiple Proglides. However, a recent study involving 122 groins contradicts the notion of vessel stenosis resulting from the double Proglide technique^[17]. In that study, vessel diameter slightly increased with a follow-up period exceeding 36 months. Larger prospective studies are warranted to comprehensively assess vessel stenosis at the access site.

A notable finding in our study was the significant increase in the access site calcification score observed in the long-term group compared to the pre-procedure assessment attributed to the use of VCDs or could reflect the natural atherosclerotic process affecting the vessel. Research investigating the impact of VCDs on vessel calcification remains limited and should be further explored.

Indeed, it is important to acknowledge the limitations of our study, including its relatively small sample size and single-center nature. Consequently, conducting larger multi-center studies with extended follow-up periods is crucial to provide a more comprehensive assessment of safety and vessel evolution. Additionally, the retrospective nature of our study may have introduced potential biases that could affect the reliability of the data.

Author Contribution

Chen.Xu. and Guo-xiong.Xu. wrote the main manuscript text and Chen.Xu. prepared figures and tables. Lei.Chen. and Zhi-xuan.Zhang. collected the data and performed the data analyses. Yi-qi.Jin. contributed to the conception of the study. The other authors state that they have no conflict of interest related to the material discussed in this article. All authors are non-partner track employees. All authors reviewed the manuscript.

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Tab.1 Baseline characteristics (patients, n=64)
Age , years	66.3 ± 13.9
Sex, male	55 (82.8)
Body mass index > 25, kg/m²	5 (7.8)
Follow-up time, months	16.1 ± 2.2
Comorbidities
Hypertension	53 (82.8)
Diabetes mellitus	14 (21.9)
Coronary artery disease	28 (43.8)
Chronic kidney disease	3 (4.7)
Peripheral arterial disease	19 (29.7)
Diagnosis
Aortic aneurysm	29 (45.3)
Aortic dissection	33 (51.6)
Penetrating aortic ulcer	2 (3.1)
Antiplatelet therapy	23 (35.9)
Anticoagulation therapy	17 (26.6)
Antiplatelet + anticoagulation therapy	9 (14.1)
Current smoking	22 (34.4)
Previous open cut-down	1 (1.6)
Previous use of vascular closure device	8 (12.5)
Procedure priority
Elective	35 (54.7)
Emergency	29 (45.3)
Procedure type
EVAR	28 (43.8)
TEVAR	6 (9.4)
FEVAR	24 (37.5)
BEVAR	6 (9.4)
Sheath size, Fr
Right	21.9 ± 1.4
Left	17.9 ± 0.9
Values are mean ± standard deviation or number (%). EVAR, endovascular aneurysm repair; TEVAR, thoracic endovascular aortic repair; FEVAR, fenestrated endovascular aortic repair; BEVAR, branched endovascular aortic repair.

Tab.2 Access site anatomy (groins, n=98)
Unilateral femoral access	30 (46.9)
Vessel diameter, mm	8.30 ± 1.53
Femoral artery depth, cm	3.10 ± 1.17
Anterior wall artery calcification	14 (14.3)
Access site calcification	1.02 ± 1.05
0 — no calcification	39 (39.8)
1 — < 33% posterior calcification	31 (31.6)
2 — 33 to 66% posterior calcification	15 (15.3)
3 — > 66% posterior	13 (13.3)
Values are mean ± standard deviation or number (%). Values are mean ± standard deviation or number (%).

Tab.3 Outcomes and access change (groins, n=98)
Technique success	98 (100)
Additional use of Proglide	2 (2.0)
Access-related complications	30 days scan	Most recent scan
Minor bleeding	3 (3.1)	0
Major bleeding	0	0
Infection	0	0
Pseudoaneurysm	1 (1.0)	0
Stenosis	0	0
Dissection	0	0
Extremity ischemia	0	0
Lymphocele	0	0
Access vessel diameter, mm	8.23 ± 1.51	8.26 ± 1.52
Femoral artery depth, cm	3.13 ± 1.16	3.08 ± 1.17
Anterior wall artery calcification	14 (14.3)	19 (19.4)
Access site calcification	1.03 ± 1.04	1.36 ± 1.08
0 — no calcification	38 (39.8)	26 (26.5)
1 — < 33% posterior calcification	32 (31.6)	30 (30.6)
2 — 33 to 66% posterior calcification	15 (15.3)	23 (23.5)
3 — > 66% posterior	13 (13.3)	19 (19.4)
Values are mean ± standard deviation or number (%).

No competing interests reported.

Long-Term Evolution of Percutaneous Groin Access in Endovascular Aneurysm Repair: A Study of the Sequential Suture and Plug Vascular Closure Devices Technique

Status:

Version 1

Abstract

Objective

Methods

Results

Conclusions

Figures

INTRODUCTION

MATERIALS AND METHODS

RESULTS

DISCUSSION

Declarations

Author Contribution

References

Tables

Additional Declarations

Status:

Version 1