A Retrospective Study Comparing the Effectiveness and Safety of EXOSEAL Vascular Closure Device to Manual Compression in Patients Undergoing Percutaneous Transbrachial Procedures

A Retrospective Study Comparing the Effectiveness and Safety of EXOSEAL Vascular Closure Device to Manual Compression in Patients Undergoing Percutaneous Transbrachial Procedures

Clinical Research A Retrospective Study Comparing the Effectiveness and Safety of EXOSEAL Vascular Closure Device to Manual Compression in Patients Un...

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Clinical Research A Retrospective Study Comparing the Effectiveness and Safety of EXOSEAL Vascular Closure Device to Manual Compression in Patients Undergoing Percutaneous Transbrachial Procedures Xiaolong Wei,1 Tonglei Han,1 Yudong Sun,2 Xiuli Sun,3 Yani Wu,4 Shiying Wang,1 Jian Zhou,1 Zhiqing Zhao,1 and Zaiping Jing,1 Shanghai, Nanjing, and Jinan China

Background: This study aimed to assess the safety and efficacy of EXOSEAL vascular closure device (EVCD) insertion by comparing its performance with manual compression (MC) in achieving hemostasis at the brachial artery puncture site. Methods: A retrospective study of brachial artery access by using either MC or EVCD for achieving hemostasis from March 2016 to October 2017 was conducted. Patients with Stanford type B aortic dissection (TBAD) undergoing percutaneous transbrachial procedures were included. Time to hemostasis (TTH) was the primary efficacy end point. Seven-day incidence of major access siteerelated complications was the primary safety end point. TTH and major and minor complications associated with treatment of these 2 groups were also evaluated. Results: A total of 157 patients with TBAD undergoing percutaneous transbrachial procedures entered the analysis. Of these, 107 patients underwent EVCD insertion and 50 patients underwent MC. The baseline characteristics of the 2 groups were similar. TTH was significantly shorter for EVCD over MC (P < 0.05). The TTH 10 min in the MC group was 100.0% (n ¼ 50), but in the EVCD group, it was 2 min, 87.9% (n ¼ 107); 2e5 min, 7.5% (n ¼ 107); and 10 min, 4.7% (n ¼ 107). The EVCD group had several major complications, while the MC group had none. Two patients (1.9%, n ¼ 107) required vascular repair, one patient (0.6%, n ¼ 107) required blood transfusion, and 1 patient (0.6%, n ¼ 107) developed upper limb numbness and weakness after EVCD deployment. Minor complication such as the occurrence of hematoma (5 cm) in the MC group was 4 (8.0%) but was also 4 (3.7%) in the EVCD group, showing statistically significant difference (P ¼ 0.030). The incidence of ecchymosis was

Xiaolong Wei, Tonglei Han and Yudong Sun contributed equally to this work. Authors’ contribution: X.W., T.H., and Y.S. contributed equally to this work. All authors confirm they contributed to the intellectual content of this article including conception and design. They revised the manuscript and approved the final version. Funding: This study was financed by the shanghai clinical research youth project (20184Y0313) and National Natural Science Foundation of China (81770482). Conflict of interest: The authors report no conflicts of interest. 1 Department of Vascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China. 2 Department of General Surgery, Nanjing General Hospital of Eastern Theater Command, Nanjing, China.

4 Department of Breast and Thyroid Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China.

Correspondence to: Jian Zhou or Zhiqing Zhao or Zaiping Jing, Department of Vascular Surgery, Changhai Hospital, 168 Changhai Road, Shanghai 200433, China; E-mails: [email protected] or [email protected] or [email protected] Ann Vasc Surg 2019; -: 1–8 https://doi.org/10.1016/j.avsg.2019.06.031 Ó 2019 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/). Manuscript received: February 12, 2019; manuscript accepted: June 16, 2019; published online: - - -

3 Department of ophthalmology, Jinan Aier Eye hospital, Jinan, China.

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8 (7.5%) in the EVCD group when compared with 13 (26.0%) in the MC group, which showed statistically significant difference (P ¼ 0.001). Other major and minor complications showed no significant differences between these 2 groups. Conclusions: After invasive procedures by 6F percutaneous access via the brachial artery in preprocedurally fully anticoagulated patients, TTH was significantly reduced in patients who underwent EVCD when compared with patients who underwent MC. MC is a safer and more convenient way to achieve hemostasis but has higher incidence of minor complications.

INTRODUCTION Endovascular procedures have been extensively and frequently used for treating arterial system diseases.1 Currently, the brachial artery access is more frequently used for endovascular interventions than before,2,3 while the femoral artery access has been the preferred route for endovascular intervention historically.4 Brachial access is considered to be a convenient and safer puncture site for aortic dissection of patients,2,3 especially when the femoral access is precluded or other arterial interventions are required during the procedure. Manual compression (MC) is a common method for achieving hemostasis of the punctured artery after clinical diagnostic studies and interventional procedures. Access site complications including bleeding, vessel occlusion, and pseudoaneurysm formation along with MC were reported to be 6%.5 However, the disadvantages of MC were also obvious, which included prolonged arm mobilization, painful at times, with strong pressure locally, as well as decreased patient compliance and satisfaction. Strategies to resolve these problems have been adopted by applying vascular closure devices (VCDs)6e9 or by choosing another arterial approach.10,11 VCDs have been used as an alternative approach to conventional MC. There are a variety of closure devices available for femoral access.6,12 Several studies showed that VCDs have better advantages than MC based on the data generated from the transfemoral artery interventions, and the effect remains uncertain when other puncture sites are considered. Although the application of several VCDs on the brachial artery has been reported to be safe and effective, hemostasis of the brachial artery access still lacked suitable and dedicated vascular occlusion devices.13e16 Recently, EXOSEAL vascular closure device (EVCD) has been more frequently used for vascular occlusion, and its safety and effectiveness have also been confirmed.8,17e19 The off-label application of EVCD to brachial artery sites also has been explored. Pieper et al.18 have reported the deployment of EVCD at the brachial puncture site and showed technically feasible results. However, studies that compared

the use of EVCD to MC at brachial puncture sites are still lacking. There are 3 types of VCDs that can be used in our center: Perclose ProGlide, AngioSeal, and EVCD. However, Perclose ProGlide is a relatively complex VCD that is commonly used for the closure of femoral artery puncture sites in our center. Angio-Seal is used to deploy an intraluminal anchor in the artery. Limited by the diameter of the brachial artery, this intravascular anchor may increase the risk of postoperative stenosis, thrombosis, or embolism. However, EVCD is an extravascular occlusion device and is a more convenient approach. Hence, we have completed the learning curve and applied EVCD in more than 300 patients for the closure of femoral artery puncture sites. Therefore, this cohort study aimed to assess the efficacy and safety of EVCD in achieving hemostasis at the brachial artery puncture site by comparing it with MC.

MATERIAL AND METHODS Study Design This was a retrospective cohort study conducted to evaluate the efficacy and safety of EVCD compared with MC for achieving brachial artery puncture site hemostasis. Between March 2016 and October 2017, patients diagnosed as Stanford type B aortic dissection (TBAD) with computed tomography angiography were included. Patients with TBAD who underwent percutaneous access via the brachial artery were included. Brachial artery access was used in the endovascular aortic procedure and provided a different approach to apply fenestration or chimney technique. Patients with the following conditions were excluded: (1) Marfan syndrome; (2) missing data on short-term follow-up; and (3) severe complications associated with aortic dissection. Based on the method used to achieve brachial artery hemostasis, patients were separated into 2 groups: EVCD group and MC group. Owing to shorter hospital stay, we observed and recorded all adverse events within 7 days of hospitalization. The flow chart was showed in Figure 1.

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Fig. 1. Flow chart of enrolled patients. Between March 2016 and October 2017, a total of 347 consecutive patients with TBAD undergoing endovascular interventions were enrolled. Of these, 216 patients underwent brachial artery puncture, and 58 patients were excluded due to

missing data and 1 death occurred due to aortic dissection ruptured. The remaining 157 patients entered analysis. Based on the method used to achieve brachial artery hemostasis, patients were separated into 2 groups: EVCD (n ¼ 107) or MC (n ¼ 50).

All decisions about therapeutic strategies and procedures were given by an experienced vascular surgeon based on clinical experience and strict technical standards. Dual antiplatelets (Aspirin, 100 mg, qd, and clopidogrel, 75 mg, qd) were prescribed preprocedurally to all selected patients (both EVCD and MC groups) during hospitalization. After brachial artery access was achieved, patients undergoing an interventional procedure were given a bolus of weight-based heparin after placement of the interventional sheath, with additional boluses given after 1 hr based on the activated clotting time. No additional heparin was given to this cohort of patients postprocedurally.

time from the removal of the introducer sheath to the timing when hemostasis was first observed. Hemostasis was defined as the termination of pulsatile bleeding in the absence of developing or expanding hematoma. Subcutaneous or cutaneous oozing was promptly treated by the application of light manual pressure. Major complications included (1) death,(2) need for vascular repair by surgical or ultrasound-guided compression, transcatheter intervention and other nonsurgical methods, (3) bleeding required blood transfusion, (4) access site infection required antibiotics, extended hospitalization or both,(5) permanent or surgery for access siteerelated nerve injury, (6) pseudoaneurysm, vascular laceration, and (7) ipsilateral manifestations of vascular embolization. Minor postprocedural complications were defined as (1) hematoma of 5 cm,(2) ecchymosis, (3) access siteerelated bleeding requiring >30 min for hemostasis, and (4) arteriovenous fistula.

Clinical Indexes and Definition TBAD was defined as aortic dissection that starts at (and involves) the left subclavian artery.20 Procedure success was defined as attainment of hemostasis using EVCD or MC without any major vascular complications during the follow-up period. The major vascular complications included access site infection, rebleeding, vascular laceration, and formation of pseudoaneurysm or vascular embolization. Cutaneous or subcutaneous oozing that was readily treated by light compression methods such as sandbags, pressure dressing, or light manual pressure complied with the definition of hemostasis. The primary effectiveness endpoint is defined as the time to hemostasis (TTH), which means that the elapsed

Procedure The diameter of the brachial artery is usually between 0.35 cm and 0.45 cm, and 6F VCD was considered suitable. A routine brachial angiogram of the target brachial artery was obtained to determine the suitability of the patient’s brachial arterial anatomy. EVCD application flow chart was shown in Figure 2. The operator inserted the EVCD to the

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Fig. 2. EVCD application flow chart. In this study, 6F VCD was chosen based on the diameter of the brachial artery. (A) The operator inserted the EVCD to the marker band through the vascular sheath and the bleed-back indicator, where the blood could be seen. (B) While the indicator wire cowling was engaged, the operator retracted the vascular sheath without advancing the EVCD. (C)

The 2 components were slowly pulled back after locking together. The marker’s color was changed when the tip of the device reached the extravascular compartment, meanwhile triggering to deploy the plug. (D) Compress the puncture site for 2~3 min (according to the product mannual) and hemostasis was achieved.

marker band through the vascular sheath and the bleed-back indicator, where the blood was observed. While the indicator wire cowling was engaged, the operator retracted the vascular sheath without advancing the EVCD. The 2 components were slowly pulled back after locking together. The marker’s color was changed when the tip of the device reached the extravascular compartment, meanwhile triggering to deploy the plug. Hemostasis was achieved when the plug was deposited on top of the vascular puncture site. The patient was then informed to maintain the left upper limb extension after the procedure and to take rest in bed for at least 6 hr. The MC group patients, with their sheaths removed, were allocated to MC after intervention. The operator compressed the brachial artery by hand for at least 15 min until the hemostasis was achieved. All patients gave prior informed consent to the intervention and were informed about the off-label use of the device. Time to deploy the device and to achieve effective hemostasis has already been recorded during these procedures by an assistant. Patients were moved to intensive care unit under close observation for several days according to their postprocedural physical conditions. Patients with puncture site rebleeding should be restricted for 2 more days before allowing for vigorous activity.

Description of VCD The EVCD (made by Cordis Company) consists of a Plug Applier and an absorbable plug. The absorbable plug is fully enclosed in the distal portion of the Delivery Shaft. The Plug Applier positions and then deploys the absorbable plug to the extravascular surface of the femoral artery access site through the existing French (F) sizeespecific procedural vascular sheath introducer, with a working length of up to 12 cm without the need for a vascular sheath introducer exchange before the deployment of the device. Hemostasis was achieved when the absorbable plug was deposited on top of the arteriotomy site. The plug exhibited partial to advanced absorption on day 30, with complete absorption between 60 and 90 days after implantation. Its application and technical success have been reported before.17,18 Analysis and Statistics Continuous variables were reported as means ± standard deviation. Skewed variables were summarized as median and range, depending on the distribution of the variables. Group comparisons were analyzed by using Student’s t-test or Wilcoxon rank-sum test for numeric variables and c2 or Fisher’s exact test for categorical variables. All

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Table I. Demographic and clinical characteristics of study population (n ¼ 157) Patient demographics

Manual compression (n ¼ 50)

EVCD (n ¼ 107)

Total (n ¼ 157)

P value

Age, year (mean ± SD) Male (%) BMI, kg/m2 (mean ± SD) Coronary artery disease (%) Hypertension (%) Diabetes (%) Renal insufficiency (%) Previous myocardial infarction (%) Previous cerebral infarction (%) Pulmonary infection (%) Peripheral vascular disease (%) Smoker (%)

60.6 ± 12.1 40 (80.0) 22.1 ± 2.2 2 (4.0) 29 (58.0) 1 (2.0) 1 (2.0) 0 1 (2.0) 0 1 (2.0) 34 (68.0)

56.4 ± 13.4 84 (78.5) 22.7 ± 1.9 7 (6.5) 69 (64.5) 4 (3.7) 4 (3.7) 1 (0.9) 3 (2.8) 1 (0.9) 5 (4.7) 59(55.2)

57.8 ± 13.1 124 (79.0) 22.5 ± 2.0 9 (5.7) 98 (62.4) 5 (3.2) 5 (3.2) 1 (0.6) 4 (2.5) 1 (0.6) 6 (3.8) 93 (59.3)

0.063 0.830 0.082 0.523 0.434 0.563 0.563 0.493 0.766 0.493 0.416 0.374

Values are median (interquartile range) or n (%). % are expressed compared to the number of patients. P value was calculated comparing MC with EVCD group.

analyses were performed using Empower(R) (www. empowerstats.com, X&Y solutions, Inc., Boston, MA) and R (http://www.R-project.org). A P value of <0.05 was considered to be statistically significant.

RESULTS Between March 2016 and October 2017, a total of 347 consecutive patients with TBAD underwent endovascular interventions. Among them, 157 patients entered analysis and were separated into 2 groups based on the method used to achieve brachial artery hemostasis: EVCD (n ¼ 107) and MC (n ¼ 50). Demographic and clinical characteristics of the study population are showed in Table I. Procedure success rate was 100.0% (n ¼ 50) in the MC group and 98.1% (n ¼ 107) in EVCD, P ¼ N/A. Two patients in EVCD required vascular repair. TTH was significantly shorter for EVCD versus MC (P < 0.001). The TTH 10 min in the MC group was 100.0% (n ¼ 50), but in the EVCD group, it was 2 min, 87.9% (n ¼ 94); 2e5 min, 7.5% (n ¼ 8); 10 min, 4.7% (n ¼ 5) (Table II). There was no statistically significant difference in the incidence of major complications between these 2 groups, especially 0.0% (n ¼ 50) in the MC group and 3.7% (n ¼ 107) in the EVCD group, P > 0.05. The complications include need for vascular repair (0.0% in MC vs. 1.9% in EVCD), bleeding required blood transfusion (0.0% in MC vs. 0.9% in EVCD), surgery for access site-related nerve injury (0.0% in MC vs. 0.9% in EVCD). No other severe events were documented (Table III). Among these minor complications, the occurrence of hematoma (5 cm) in the MC group was 8.0%

(n ¼ 50), but it was 3.7% (n ¼ 107) in the EVCD group, showing statistically significant difference (P ¼ 0.030). The incidence of ecchymosis was 7.5% (n ¼ 107) in the EVCD group when compared with 26.0% (n ¼ 50) in the MC group, which was statistically significant (P ¼ 0.001). The other minor complications include access siteerelated bleeding requiring >30 min to hemostasis and arteriovenous fistula, which were not significantly different (Table IV).

DISCUSSION Several studies have reported that the application of VCD significantly reduced the TTH and ambulation in patients who have undergone endovascular procedures.17,21,22 According to recent randomized clinical trials and registries, VCD demonstrated a more than 60% reduction in TTH and more than 50% reduction in vascular complications when compared with MC.23,24 The use of VCDs in brachial artery site is very limited. In recent years, the application of AngioSeal vascular closure device (AVCD) on brachial artery has been reported to be safe and feasible. Belenky et al. inserted AVCDs in 64 patients after performing diagnostic or therapeutic arterial angiographies via distal brachial artery. The deployment success rate was 100%, and no major complications were encountered.15 Bilecen et al.16 described a strategy for the off-label use of 6F-AVCD deployment for puncture closure of the brachial artery after transbrachial PTA. The results showed that AVCD was successfully deployed in 36 patients, and hemostasis was achieved within several minutes. Lupattelli et al.14 applied AVCDs in 79 patients, and the success rate for achieving

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Table II. Safety and effectiveness findings Findings

Procedure success rate (%) Time to hemostasis (TTH) 2 min 2e5 min 10 min

Manual compression (n ¼ 50)

EVCD (n ¼ 107)

Total (n ¼ 157)

P value

50 (100.0)

105 (98.1)

155 (98.7)

0 0 50 (100.0)

94 (87.9) 8 (7.5) 5 (4.7)

e <0.001 e e e

Values are median (interquartile range) or n (%). % are expressed compared to the number of patients. P value was calculated comparing MC with EVCD group.

hemostasis was 96.9%. Five major complications (3.1%) on day 30 included 2 puncture site hematomas of >4 cm, 2 brachial artery occlusions, and one brachial artery pseudoaneurysm, and 3 patients required open surgery. In addition to AVCD, StarClose device and EVCD have successfully achieved hemostasis on the brachial artery.13,18 Although there are no specific devices designed for the closure of transbrachial procedures, these attempts have proved that it is feasible to use the occlusion device for hemostasis at the brachial artery puncture site. EVCD has been originally designed for closure of femoral puncture sites and has been widely used in clinical vascular closure procedures for longer periods.8,18,19,25e31 Boschewitz et al.19 applied EVCD in 148 patients and achieved 98% technical success rate and also reported that the use of EVCD in antegrade femoral punctures was safe and effective with low complication rate. Pieper et al.8 successfully used EVCD in 25 patients, and they provided a questionnaire regarding the pain levels for EVCD and MC patients after undergoing the procedure. The patients demonstrated discomfort, which was significantly lower after EVCD use than in MC.8 Grandhi et al.27 achieved femoral access site hemostasis by EVCD in 98 patients, and the long-term follow-up results after EVCD application showed a low risk of clinically significant delayed angiographic findings.

Satisfactory hemostasis can be achieved by applying EVCD device at the puncture site of the femoral artery. In addition, EVCD is an extravascular occlusion device, while AVCD is an intravascular occlusion device. The intravascular anchor has a theoretical risk of stenosis, thrombosis, or embolism.18,32,33 According to our clinical experience, we hypothesized that EVCD less likely causes brachial artery stenosis or occlusion when compared with AVCD. Pieper et al.18 implemented EVCD on an off-label basis on the transbrachial artery in 7 patients and reported that 1 patient had device failure with a minor hematoma, proving that the application of EVCD in the treatment of brachial artery hemostasis was technically feasible. In this study, we used 6F-EVCD as the best choice based on the diameter of the brachial artery. In the present study, the technical success rate of EVCD deployment was 98.1% (n ¼ 107). Two patients required vascular repair. A 37-year-old patient was treated with vascular repair for hemostasis because of unsuccessful repeated EVCD deployment. The effect of hemostasis by subsequent MC remained unsatisfactory. A small longitudinal cutdown was performed on the medial aspect of the upper arm, and then the brachial artery puncture site was sutured. Another 65-year-old patient

Table III. Major complications after procedure within 7 days Major complications

Manual compression (n ¼ 50)

EVCD (n ¼ 107)

Total (n ¼ 157)

P value

Death (%) Need for vascular repair (%) Bleeding required blood transfusion (%) Access site infection (%) Access siteerelated nerve injury (%) Pseudoaneurysm (%) Vascular laceration (%) Brachial artery embolization (%)

0 0 0 0 0 0 0 0

0 2 (1.9) 1 (0.9) 0 1 (0.9) 0 0 0

0 2 (1.3) 1 (0.6) 0 1 (0.6) 0 0 0

e 0.331 0.493 e 0.493 e e e

Values are median (interquartile range) or n (%). % are expressed compared to the number of patients. P value was calculated comparing MC with EVCD group.

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Table IV. Minor complications after procedure within 7 days Minor complications

Manual compression (n ¼ 50)

EVCD (n ¼ 107)

Total (n ¼ 157)

P value

Hematoma 5 cm (%) Ecchymosis (%) >30 min to hemostasis Arteriovenous fistula (%)

4 (8.0) 13 (26.0) 0 0

4 (3.7) 8 (7.5) 0 0

8 (5.1) 21 (13.4) 0 0

0.030 0.001 e e

Values are median (interquartile range) or n (%). % are expressed compared to the number of patients. P value was calculated comparing MC with EVCD group.

had accidental tearing of the brachial artery when the sheath was withdrawn. The application of EVCD did not achieve satisfactory hemostasis, and so we performed an open surgery and sutured the rupture site of the brachial artery with simultaneous blood transfusion. One patient developed upper limb numbness and weakness after EVCD deployment, which were relieved but still existed at the time of discharge. This might be due to prolonged surgery or damage to the nutrient artery of the nerve by EVCD. Therefore, it is necessary to have anatomy knowledge of the upper limb and also required proficiency in the application of EVCD. Although there are several serious complications in the application of EVCD, these can be completely avoidable. According to our experience, EVCD is efficient and safe for hemostasis, probably more comfortable for the patient but also more expensive (400$ paid by the patient) while MC is almost free in China. Perhaps, in the future, the price of EVCD will be reduced so that more patients can enjoy the convenience and satisfactory experience brought by this technology. Our recent research has confirmed EVCD as a valid alternative method for vascular closure. Limitations The results of our research might be limited by short-term observation. It still needs longer followup periods. The VCD we selected was not designed for the brachial artery. Although the treatment has achieved a satisfactory result, an experimental device that is more representative is still warranted.

CONCLUSIONS In this retrospective cohort study, TTH was significantly reduced in patients who underwent EVCD when compared with that in patients who had MC. No statistically significant difference was observed in major complications, while EVCD had several major complications but MC had none. MC

is a safer and more convenient way to achieve hemostasis, while it has a higher incidence of minor complications. For EVCD, the vascular surgeons should be properly trained on how to use this, and its application in brachial artery puncture site is also a safe and effective method when compared with traditional MC. Further clinical studies are required to verify the comparative safety and efficacy of EVCD with other VCDs, and it can be used in diverse patient cohorts.

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