Outcomes of Brachial Artery Access for Endovascular Interventions

Accepted Manuscript Outcomes of Brachial Artery Access for Endovascular Interventions Nicholas J. Madden, Keith D. Calligaro, Hong Zheng, Douglas A. Troutman, Matthew J. Dougherty PII:

S0890-5096(18)30802-1

DOI:

https://doi.org/10.1016/j.avsg.2018.07.061

Reference:

AVSG 4062

To appear in:

Annals of Vascular Surgery

Received Date: 24 May 2018 Revised Date:

17 July 2018

Accepted Date: 17 July 2018

Please cite this article as: Madden NJ, Calligaro KD, Zheng H, Troutman DA, Dougherty MJ, Outcomes of Brachial Artery Access for Endovascular Interventions, Annals of Vascular Surgery (2018), doi: https:// doi.org/10.1016/j.avsg.2018.07.061. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Outcomes of Brachial Artery Access for Endovascular Interventions

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Nicholas J. Madden, Keith D. Calligaro,

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Hong Zheng, Douglas A. Troutman, Matthew J. Dougherty

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Section of Vascular Surgery, Pennsylvania Hospital

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800 Spruce St

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Philadelphia, PA 19107

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Nicholas J. Madden

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Corresponding Author:

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700 Spruce St. Suite # 101 Philadelphia, PA 19106 Phone: 215-829-5000 Fax: 215-627-0578

Email: [email protected]

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Keywords: brachial, percutaneous, endovascular

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Abstract

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Objectives: A percutaneous brachial artery (BA) approach is a suitable or even favorable

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alternative to femoral artery access when performing certain endovascular interventions.

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However, this approach may have a higher complication rate compared to femoral artery access.

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We analyzed our results using percutaneous BA approach for non-cardiac endovascular

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interventions.

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Methods: Between January 1, 2003 – December 31, 2017, BA access was used in 157 cases

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performed on 136 patients. The procedures included 102 (65%) therapeutic interventions and 55

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(35%) diagnostic studies. The vessels studied or treated included lower extremity arteries (48),

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the aorta and iliac arteries (45), mesenteric arteries (45), failing arterial revascularizations (24),

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renal arteries (9), subclavian arteries (8), carotid arteries (2), and visceral aneurysms (2), or in

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conjunction with EVAR, FEVAR, or TEVAR (8). More than one vessel was studied or treated

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in 34 cases. Sheath sizes included 5 French (Fr) in 38 (24%) cases, 6 Fr in 93 (59%) cases, and 7

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Fr in 26 (17%) cases. Percutaneous puncture was utilized in 142 (90.4%) cases and planned

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surgical exposure with primary closure of the BA in 15 (9.6%) cases (10 7Fr, 4 6Fr, 1 5Fr).

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Manual compression was used for hemostasis at the conclusion of all percutaneous cases.

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Results: There were two (1.3%; 2/157 cases) deaths in the peri-operative period, one due to

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myocardial infarction and the other from mesenteric ischemia. Access site complications

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occurred in 10.6% (15/142) of percutaneous cases, which required open surgical repair for

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bleeding (8) and brachial artery thrombosis (7). There was an increased risk of complications

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with increasing sheath size with the percutaneous approach: 5.4% (2/37), 12.4% (11/89), and

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12.5% (2/16) for 5Fr, 6Fr, 7Fr sheaths, respectively (p =0 .49). None of the 15 patients who

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underwent surgical treatment suffered long-term vascular or neuropathic complications.

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Conclusion: In our experience, percutaneous BA access was associated with a 10% complication

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rate with an increased risk of complications associated with increasing sheath size. There was

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approximately the same incidence of bleeding as thrombosis. For patients who require 6 or 7 Fr

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sheaths via a BA approach, we recommend more liberal use of open surgical exposure and

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primary BA repair.

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Introduction: While femoral artery access has historically been the preferred route for peripheral vascular interventions, brachial artery (BA) puncture is now being used with increasing

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frequency. The decision to proceed with BA access may be multi-factorial. Previous

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interventions such as an aortic bifurcated graft or endovascular aneurysm repair (EVAR),

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unfavorable native aorto-iliac anatomy, parallel graft placement, or scarred or infected groins are

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all possible considerations.

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While complications of femoral artery access are extensively reported on in the literature

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and range from 1.4% - 3.7%1,2, access complications associated with the BA have been

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documented less frequently. Previous reports of BA access complications have been reported to

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exceed 10% in some series3-5. However, these reports have not been consistent in terms of

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defining complications, how access was obtained, sheath size, and type of intervention being

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performed.

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In the present study, we analyze our experience with BA access for endovascular

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interventions and attempt to identify factors that may contribute to access related complications.

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Methods:

This is a single institution retrospective review of patients treated on the vascular service

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utilizing a prospectively maintained database performed in a de-identified manner. All patients

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who underwent BA access for endovascular interventions from January 1, 2000 – December 31,

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2017 at Pennsylvania Hospital were included in the analysis. Institutional review board approval

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was deferred given the de-identified nature of our database in accordance with our institution

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review board’s protocol. Data collection included patient demographics, operative indications,

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operative technique, sheath size, peri-operative complications, and major adverse events

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(MAEs). MAEs were defined to include myocardial infarction, congestive heart failure, renal

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insufficiency, surgical site infection, stroke, respiratory complications, and death.

The decision to use the BA was made at the discretion of the operative surgeon based

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upon previous interventions, patient disease location, and technical considerations. The choice

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of percutaneous access or a BA cut-down was likewise at the discretion of the operative surgeon.

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For percutaneous interventions, access was obtained using ultrasound guidance with a Potts

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needle (Procedure Products, Inc., Vancouver, WA) but more recently with a Micropuncture

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Access Kit (Cook Medical, Bloomington, IN). Standard Seldinger technique was utilized for

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sheath upsizing. Pinnacle Destination (Terumo, Somerset, NJ) or Ansel sheaths (Cook Medical,

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Bloomington, Indiana) were used in all cases. All patients were systemically heparinized after

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access was obtained to maintain the activated clotting time (ACT) > 200 seconds. Manual

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compression was used at the conclusion of the percutaneous procedures to achieve hemostasis.

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Direct digital pressure was applied by the vascular surgery attending or vascular surgery fellow

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in the operating room for a minimum of 5 minutes per French diameter (e.g. 7Fr sheath = 35

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minutes of direct pressure). For elective cut-downs, the puncture site was closed with 6-0

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polypropylene suture. A posterior splint was applied and the arm immobilized with an ace

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bandage for 6 hours following the procedure regardless of whether a percutaneous or open

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approach was used.

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The decision to return to the operating room for an access-related complication was made by the attending surgeon. Symptoms of neuropathy or ischemia as well as an expanding

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hematoma were absolute indications for re-exploration.

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Statistical analysis: De-identified data points were analyzed in Excel (Microsoft

Corporation, Redmond, WA). Means, standard deviations, Fisher’s exact test, and Forest plot

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analyses were utilized in a standard manner.

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Results:

A total of 157 endovascular procedures were performed via the BA on 136 patients.

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Patient demographics and comorbidities are listed in Table 1. The average age was 58.3 years

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and 53% of patients were male. The procedures were therapeutic in 102 cases (65%) and

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diagnostic in 55 (35%). The vessels imaged are listed in Table 2. The majority of territories

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studied and treated were the aorto-iliac system and the abdominal branches (69%). Eight

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interventions were performed in conjunction with endovascular aneurysm repair (EVAR),

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fenestrated EVAR (FEVAR), or thoracic EVAR (TEVAR). More than one segment was studied

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or treated in 34 cases. In the 102 intervention cases, a total of 191 arterial segments or bypasses

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were treated.

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A percutaneous puncture was used in 142 (90.4%) cases while planned surgical cut-down

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with primary closure of the BA was used in 15 (9.6%) (Table 3). Sheath size ranged from 5Fr to

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7Fr with 6Fr being the most common (n = 93, 59%), followed by 5Fr (n = 38, 24%), and 7Fr (n =

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26, 17%). For patients undergoing a planned surgical cut-down, 10 (66%) needed a 7Fr sheath, 4

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(27%) a 6Fr sheath, and 1 (7%) a 5Fr sheath. None of the percutaneous cases required intra-

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operative conversion to a cut-down to gain arterial access, therefore the technical success of

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gaining access via a percutaneous approach was 100%. Major adverse events within the 30-day peri-procedure period included two deaths. One

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patient died due to a myocardial infarction and the other secondary to sepsis from progressive

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mesenteric ischemia. Access site complications requiring surgical repair occurred in 10.6%

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(15/142) of percutaneous cases (Table 3): 8 (53%) for bleeding and 7 (47%) for thrombosis. All

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complications were identified in the immediate post-operative period (6 in the operating room, 9

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in the recovery room). In patients with bleeding and a brachial sheath hematoma, median

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neuropathy was the most frequently reported symptom (7/8, 87.5%). One of 8 was found to have

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a pseudoaneurysm. Relative risks for patient and intra-operative variables are displayed in

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Tables 4 & 5. There was no statistically significant difference in complication rate by patient or

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intra-operative variables (p = NS for all variables). . Past history of BA access for intervention

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and use of protamine was protective of an access related complication (RR 0.23 and 0.51,

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respectively). There was an increased risk of complications with increasing sheath size: 5.4%

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(2/37), 12.4% (11/89), and 12.5% (2/16) for 5Fr, 6Fr, and 7Fr, respectively (p = 0.49), Table 3.

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The relative risk of an access related complication for a 6Fr and 7Fr sheath was 2.28 and 2.31,

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respectively (p = 0.26 and 0.38, respectively). None of the percutaneously treated patients

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requiring BA exploration were found to have additional complications at the time of post-

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operative follow-up. None of the planned cut-downs required re-exploration.

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Discussion: The use of a BA approach for endovascular procedures has become increasingly common in recent years and has been reported to have a higher degree of morbidity compared to

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traditional femoral access1-5. These reports have demonstrated that access related complications

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increase with increasing sheath size in some series. A vascular quality initiative (VQI) registry

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report confirmed that sheath size larger than 5Fr was predictive of access related complications,

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while male gender and planned BA cut-down were protective6. We agree that planned cut-down

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is associated with a low risk of access-related complications (0% in this series). However, due to

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the limitations of a registry-based study, the VQI authors could not stratify complications based

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on specific sheath size. Our results show that interventions performed with a 5Fr sheath can be

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performed with low access site morbidity (5.4%). Use of larger sheath sizes (6-7Fr) doubled the

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rate of access related complications in our experience. For patients requiring these larger sheath

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sizes, we recommend more liberal use of elective cut-downs to expose and repair the brachial

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artery. These small incisions can be performed using local anesthesia and were well-tolerated.

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In this series, there were no complications associated with planned BA cutdown regardless of the

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sheath size used. We have a low threshold to explore patients who develop hematomas as we

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want to avoid median neuropathy.

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One of the most recent reports on BA access by Franz et al focused on access for lower

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extremity interventions only7. Sheath sizes in this study were not independently stratified but the

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majority of the interventions were performed with a 5F sheath. Similar to our series, they

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reported a relatively low rate of access site complications for smaller sheath sizes. The majority

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of patients in this report (59%) underwent balloon angioplasty alone. This is an important

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distinction from our study because use of atherectomy devices, stents or stent grafts requires

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larger sheaths and is likely associated with higher risk of complications. While there seems to be consensus that selected peripheral interventions can be addressed

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from the BA with a small sheath with low morbidity7-9, the increasing frequency of complex

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endovascular aneurysm repair requires special consideration. It has been estimated that 30% of

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all infrarenal abdominal aneurysms are not amenable to current commercially available standard

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EVAR devices10,11. With emerging technology, vascular surgeons can now offer patients repair

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of a larger percentage of these aneurysms using parallel grafts and fenestrated technology12. To

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facilitate repair with these technologies, alternative access such as the brachial artery or axillary

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artery are frequently necessary. In our series, percutaneously placing a 7Fr sheath in the BA was

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associated with a complication rate exceeding 12%. As a result we have adopted a more liberal

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strategy of using brachial artery cut-downs in conjunction with performing fenestrated grafts or

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inserting parallel visceral or renal artery stent grafts.

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Another option for arterial access when performing complex endovascular repair is the axillary artery. Sheath sizes of 12Fr and up to three 7Fr sheaths have been placed in the axillary

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artery for delivery of visceral or renal stent grafts13,14. The reported complications of axillary

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artery exposure include wound hematomas and brachial plexus injuries with a reported incidence

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in the range of 3-7%13-15. Additionally, proximal brachial artery cut-downs have been proposed

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to allow placement of larger sheaths while avoiding the potential morbidity of axillary artery

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exposure, but the smaller diameter of the proximal brachial artery compared to the larger axillary

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artery is often a limiting factor16.

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Interestingly, the incidence of bleeding and thrombotic complications occurred with about equal frequency in our series. This finding highlights the challenge of manual compression

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of the brachial artery. One must apply enough digital pressure for a sufficient length of time to

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prevent bleeding but not so much that arterial thrombosis results. Lastly, although no patients

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suffered post-operative complications if they required surgical exploration for bleeding or

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clotting after a percutaneous BA approach, they did experience incisional pain and arm

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discomfort and swelling, which is usually avoided when a percutaneous approach was

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unassociated with complications.

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Our study was limited by its retrospective nature and relatively small sample size. Although a number of the variables tested conveyed an increased relative risk for BA access,

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they failed to reach statistical significance, which again we believe is due to the sample size.

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Additionally, further distinction between therapeutic and diagnostic procedures may be

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necessary (e.g. – frequent sheath or catheter exchanges and the associated trauma to the BA).

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We believe additional studies with larger sample sizes are warranted. In conclusion, although the safety of percutaneous BA access may have improved with

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the routine use of ultrasound and micropuncture needles, this approach carries a high rate of

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complications often mandating surgical repair. We believe surgical exposure of the BA should

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be considered for sheath size greater than 5Fr, particularly in patients with small arterial size on

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duplex ultrasound visualization.

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1. Seto AH, Abu-Fadel MS, Sparling JM, Zacharias SJ, Daly TS, Harrison AT, et al. RealTime Ultrasound Guidance Facilitates Femoral Arterial Access and Reduces Vascular Complications. JACC Cardiovasc Interv. 2010; 3(7): 751-8. 2. Inagaki E, Farber A, Siracuse JJ, Mell MW, Rybin DV, Doros G. Routine Use of Ultrasound Guidance in Femoral Arterial Access for Peripheral Vascular Intervention Decreases Groin Hematoma Rates in High-Volume Surgeons. Ann Vasc Surg. 2018; Epub ahead of print 3. Alvarez-Tostado JA, Moise MA, Bena JF, Pavkov ML, Greenberg RK, Clair DG, et al. The Brachial Artery: A Critical Access for Endovascular Procedures. J Vasc Surg. 2009; 49(2): 378-85. 4. Stavroulakis K, Usai MV, Torsello G, Schwindt A, Stachmann A, Beropoulis E, et al. Efficacy and Safety of Transbrachial Access for Iliac Endovascular Interventions. J Endovasc Ther. 2016; 23(3): 454-60. 5. Watkinson AF, Hartnell GG. Complications of Direct Brachial Artery Puncture for Arteriography: A Comparison of Techniques. Clin Radiol. 1991; 44(3): 189-91 6. Kret MR, Dalman RL, Kalish J, Mell M. Arterial cutdown reduces complications after brachial access for peripheral vascular interventions. J Vasc Surg. 2016; 64(1): 149-154 7. Franz RW, Tanga CF, Herrmann JW. Treatment of Peripheral Arterial Disease via Percutaneous Brachial Artery Access. J. Vasc Surg. 2017; 55(2): 461-65. 8. Treitl KM, Konig C, Reiser MF, Treitl M. Complications of Transbrachial Arterial Access for Peripheral Endovascular Interventions. J Endovasc Ther. 2015; 22(1): 63-70. 9. Armstrong PJ, Han Dc, Baxter JA, Elmore JR, Franklin DP. Complication Rates of Percutaneous Brachial Artery Access in Peripheral Vascular Angiography. Ann Vasc Surg. 2003; 17(1): 107-10. 10. Ricotta JJ 2nd, Oderich GS. Fenestrated and Branched Stent Grafts. Perspect Vasc Endovasc Ther. 2008; 20(2): 174-87. 11. Bruen KJ, Feezor RJ, Daniels MJ, Beck AW, Lee WA. Endovascular Chimney Technique Versus Open Repair of Juxtarenal and Suprarenal Aneurysms. J Vasc Surg. 2011; 53(4): 895-904. 12. Li Y, Hu Z, Bai C, Liu J, Zhang T, Ge Y, et al. Fenestrated and Chimney Technique for Juxtarenal Aortic Aneurysm: A Systematic Review and Pooled Data Analysis. Sci Rep. 2016; 6:20497. 13. Lee JT, Greenberg JI, Dalman RL. Early Experience with the Snorkel Technique for Juxtarenal Aneurysms. J Vasc Surg. 2012. 55(4): 935-46. 14. Knowles M, Nation DA, Timaran DE, Gomez LF, Baig MS, Valentine J, et al. Upper Extremity Access for Fenestrated Endovascular Aortic Aneurysm Repair is Not Associated with Increased Morbidity. J Vasc Surg. 2015. 61(1): 80-87. 15. Wooster M, Powell A, Back M, Illig K, Shames M. Axillary Artery Access as an Adjunct for Complex Endovascular Aortic Repair. Ann Vasc Surg. 2015. 29(8): 1543-7.

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References:

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16. Stern JR, Ellozy SH, Connolly PH, Meltzer AJ, Schneider DB. Utility and Safety of Axillary Conduits During Endovascular Repair of Thoracoabdominal Aneurysms. J Vasc Surg. 2017. 66(3): 705-10.

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Table 1: Baseline demographics and patient characteristics Average (years) + SD 58.3 + 8.65

Age

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7 (5) 4 (3) 8 (6) 18 (13) 16 (12) 8 (6)

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Table 2: Vascular territories studied

Lower Extremity Arteries Aorta/Iliac Arteries Mesenteric Arteries Failing arterial bypasses or stents Renal arteries Subclavian Arteries EVAR/FEVAR/TEVAR Carotid Arteries Visceral Aneurysms > 1 Segment Treated 283

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72 (53) 64 (47) 113 (83) 34 (25) 94 (69) 27 (20)

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Gender Male Female Hypertension Diabetes Hyperlipidemia COPD Tobacco Use Current Former Renal Insufficiency CKD ESRD CHF Coronary Disease Prior MI CABG PTCA

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N (%)

n 48 45 45 24 9 8 8 2 2 34

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Table 3: Complications of planned cut-down and percutaneous brachial artery access n (%) 15 1 (7) 4 (27) 10 (66) 142 37 (26) 89 (63) 16 (11)

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Planned cut-down 5Fr 6Fr 7Fr Percutaneous access 5Fr 6Fr 7Fr

Surgical Exploration n (%) 0 0 0 0 15 (10.6) 2 (5.4) 11 (12.4) 2 (12.5)

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Table 4: Forest plot of patient and intra-operative variables and the need for re-exploration

Hypertension

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Hyperlipidemia COPD

Current Tobacco

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CAD

Protamine DM Female Therapeutic Intervention Previous Brachial Access 6 Fr Sheath 7 Fr Sheath

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COPD = chronic obstructive pulmonary disease; CKD = chronic kidney disease; CAD = coronary artery disease; DM = diabetes mellitus; Fr = French

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Table 5; Relative risk, confidence intervals and p-values for patient and intra-operative variables

Current Tobacco CKD CAD Protamine DM Female Therapeutic Intervention Previous Brachial Access 6 Fr Sheath 7 Fr Sheath

1.48 (0.49 - 4.4) 0.23 (0.01 - 3.7) 2.28 (0.53 - 9.8) 2.31 (0.35 - 15)

p value 0.2 0.46 0.68 0.32 0.97 0.16 0.27 0.43 0.29

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COPD = chronic obstructive pulmonary disease; CKD = chronic kidney disease; CAD = coronary artery disease; DM = diabetes mellitus; Fr = French; CI = confidence interval

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(95% CI) 6.15 (0.38-99) 1.57 (0.46 - 5.3) 1.39 (0.47 4.07) 0.48 (0.11 2.05) 1.03 (0.15 - 7.1) 2.01 (0.74 5.44) 0.51 (0.15 - 1.7) 1.5 (0.54 - 4.1) 1.7 (0.63 - 4.56)

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Patient & IntraOperative Variables Hypertension Hyperlipidemia

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