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True Femoral Arterial Puncture Site vs Perceived Arterial Puncture Site Najam Wasty, MD; Vadim Spektor, MD; Zeshan Rana, MD; Daniel Tsyvine, MD; Gurinder Rana, MD; Muhammad Khakwani, MD; Marc Cohen, MDFrom Newark Beth Israel Medical Center, Newark, New Jersey.

ABSTRACT: Introduction: Angiography is often performed following femoral arterial access for catheter-based

procedures typically with the sheath angled away medially to determine the arterial puncture site location. This information

is factored into decisions regarding deployment of a closure device. We hypothesized that determining the puncture site

using the above technique may be inaccurate. Methods: We retrospectively analyzed 200 baseline femoral sheath

angiograms (FSA) in a 35-degree ipsilateral oblique view with sheath angled medially away from the common femoral

artery (CFA). The standard of care at our facility is to perform imaging using fluoroscopic subtraction angiography

(“roadmapping”) capturing a contrast-filled Mynx balloon (MB; AccessClosure, Inc.) as it is withdrawn to the true arterial

puncture site (TAPS) during closure device deployment. Three independent operators, blinded to MB images, were

asked to mark the perceived arterial puncture site (PAPS) on baseline angiograms. The PAPS was then compared with

TAPS (the center of the MB margin abutting the vessel wall), and the distance between the two points was measured.

Results: TAPS was >3 mm caudad to PAPS in >80% of patients. Incidentally TAPS determined in this fashion correlates

to the site where the angled sheath silhouette crosses the CFA silhouette. Conclusion: Commonly used techniques

for isolating TAPS are often imprecise. When making decisions regarding closure devices, operators must be mindful of

the fact that TAPS is often significantly lower than PAPS. Incidentally, a useful indicator of TAPS is the point where the

angled sheath silhouette crosses the CFA silhouette in a 35-degree ipsilateral oblique view FSA.

VASCULAR DISEASE MANAGEMENT 2015;12(11):E215-E220 Key words: angioplasty, catheterization, interventional cardiology, vascular intervention,

access site management

Percutaneous catheterization, for the performance

of catheter-based vascular procedures, has long

been achieved via access in the femoral artery.1

Within the past decade, alternative access sites such as

the radial artery have increased in popularity. Nev-

ertheless, the majority of invasive catheterization

operators in the United States still access the femoral

artery because of relative ease of use, range of sheath

sizes, and personal familiarity. However, in spite of

decades of experience with femoral artery access, vas-

cular access site complications, especially bleeding,

continue to occur.2,3

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The standard of care at our facility is a novel tech-

nique that employs the fully withdrawn contrast filled

Mynx balloon (MB; AccessClosure, Inc.), to identify

the location of the puncture site.4 Using this tech-

nique, we tested the hypothesis that the true arterial

puncture site (TAPS) is not in the same location as

the PAPS, as determined by the traditional method

described above.

METHODSWe use the Mynx device as our “workhorse” vas-

cular closure device (VCD). It is our standard prac-

tice that at the end of the procedure a baseline FSA

at 17˝ magnification and right anterior oblique of 30

degrees is performed with the sheath angled medially,

as far away as is possible without losing arterial access

(Figure 1). Immediately following this angiogram, the

Mynx device is placed in the vessel through the sheath

and the contrast-filled balloon is inflated and visual-

ized under flouroscopy in exactly the same view and

magnification. Because motion artifact is always a po-

tential source of error when using roadmapping, once

we are satisfied that there is no patient, table, or image

intensifier movement, the roadmap mode is quickly ac-

tivated and the vessel is opacified with contrast injected

through the sheath sidearm, thus obtaining a roadmap

FSA. The inflated radio-opaque MB is clearly visible

at this time at the tip of the unwithdrawn sheath. The

MB is then swiftly withdrawn as per manufacturer

deployment instructions to the arteriotomy site and

abutment against TAPS is confirmed by documenting

lack of bleed back from the side arm. This roadmap

FSA is then “saved” (Figure 2). This modified Mynx

deployment technique of filling the MB with contrast

has been previously described by our group in a large

case series, capturing the MB under fluoroscopy as it

was withdrawn to the TAPS during MB deployment.5,6

The closure device deployment is then completed by

tamping down the extravascular polyethylene glycol

sealant as per manufacturer instructions. For initial

CFA access, ultrasound guidance was not used in our

patients, nor was it customary in cardiology labs for

routine CFA access at the time of this study.

After obtaining institutional review board approval,

we retrospectively analyzed 200 consecutive studies

and made a set of three hard copies (HC 1A, 1B, 1C)

of the baseline FSA (Figure 1), which were printed

and distributed to three independent observers to pin-

point with a sharp ball point pen the PAPS. A second

Figure 1. Femoral Artery Sheath Angiogram. The Perceived Arterial Puncture Site (PAPS) is where the medially angulated sheath bends against the opposing wall of the common femoral artery (CFA). CFA Sil, CFA silhouette; AnSS, angulated sheath silhouette.

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hard copy (HC2) of the saved roadmap FSA with the

MB withdrawn to TAPS was also printed (Figure 2).

TAPS was pinpointed with a pen on HC2. The TAPS

was depicted by a point on the horizontal line travers-

ing the center of the MB where the line crossed the

medial border of the CFA silhouette. The three PAPS

hard copies (HC 1A, 1B, and 1C) were then sequen-

tially placed on top of the TAPS hard copy (HC2)

in a successive fashion, and each time the PAPS was

projected from HC 1 A, 1B, and 1C onto HC2 with

a pen. These 3 PAPS were labelled A, B, and C on

HC2 (hard copy of the TAPS). If PAPS marked by two

different independent observers were within .5 mm

of each other they were considered to be one PAPS.

Additional horizontal lines were then drawn through

PAPS A, B, and C on HC2, which already had the

horizontal line depicting TAPS on it. The vertical

distance between each horizontal line depicting PAPS

A, B, and C and the horizontal line depicting TAPS

in the same patient, was then measured and carefully

catalogued for final calculations.

PATIENT POPULATIONInclusion criterion for this study was any patient 18

years of age or older having undergone diagnostic or

interventional coronary or peripheral endovascular

procedure via a CFA access, in whom a Mynx VCD

had been used.

STATISTICSFrequencies are presented as the mean ± the standard

deviation. To discern the mean distance from PAPS

to TAPS, the distance was measured and rounded off

to the nearest 1mm. The Student t test was used to

explore if this difference was other than zero. The

Analysis of Variance (ANOVA) technique was used to

obtain the necessary variance components to calculate

the reliability coefficient for this continuous outcome.

To test the rater’s ability to distinguish caudad from

cephalad, such as for dichotomous responses, multirater

kappa (k) statistics, or the chance adjusted measure of

agreement, were used to evaluate the intraobserver

reliability among the 3 reviewers using a SAS macro

called “magree.sas.” The range for k is from -1 (com-

plete discordance among reviewers) to 0.0 (random

chance) to +1 (perfect concordance among reviewers).

All data were analyzed using SAS system software

(SAS Institute Inc.).

 

Figure 2. Roadmap fluoroscopy of contrast-filled Mynx ballon as it is withdrawn from starting point (Point A) to Point B where it abuts the common femoral artery arteriotomy site, also the true arterial puncture site (TAPS).

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RESULTSFemoral artery angiograms of 200 consecutive pa-

tients with Mynx VCD usage were analyzed in this

study. Patient demographics are tabulated in Table 1.

One hundred and eleven patients (56%) were male,

and the mean weight was 83.8 kg. The mean distance

for the entire cohort of TAPS being caudad to PAPS

was 4.4 mm ± 1.7 mm. Only 18.8% of patients dem-

onstrated a TAPS to PAPS caudad difference of <3

mm, while 81.2% demonstrated the TAPS to PAPS

caudad distance to be >3 mm. In 30.4% of patients,

the TAPS was as far as 5 mm or more caudad to

the PAPS (Table 2). Incidentally, in 97% of patients,

TAPS is exactly the point where the angled sheath

silhouette crosses the CFA silhouette in a 35-degree

ipsilateral oblique view FSA. In spite of TAPS almost

always being caudad to PAPS, there were no signifi-

cant clinical adverse events noted in the first 30 days

of follow-up, which may be attributable to the fact

that the Mynx VCD used in all cases in this study is

totally extravascular and is known not to negatively

impact low CFA bifurcation sticks. In 15% of cases

the operators identified a “low stick;” or perceived

to be below the CFA bifurcation, and in the remain-

ing 85% of cases, operators perceived the sticks to be

above the bifurcation. Among these 85%, we did not

routinely analyze the position of TAPS in relation

to the CFA bifurcation to obtain an exact percent

of patients in whom PAPS was felt to be “safe,” or

above the bifurcation, but TAPS was in fact below.

DISCUSSIONComplications from percutaneous, invasive cardio-

vascular procedures via femoral access range from

minor bleeding, hematoma, fistula formation, and

pseudoaneurysm to, less commonly, catastrophic

retroperitoneal hemorrhage.2,3,7-10 The likelihood of

these complications occurring as well as the mor-

bidity associated with them is clearly affected by the

location of the arterial puncture; whether into, be-

low, or above the CFA, and/or inguinal ligament.

This study challenges confidence in identifying the

puncture site from the FSA, which most operators

in the angiography suite take for granted. Using 3

different interventionalists to review baseline images

depicting PAPS on FSA and comparing them to FSA

images with a contrast-filled MB abutting the true

arteriotomy site depicting TAPS, we demonstrated

 

Figure 3. Femoral artery sheath angiogram: figures 1 and 2 overlapped. True arterial puncture site (TAPS) is typically where the angled sheath silhouette (AnSS) crosses the common femoral artery silhouette (CFA Sil).

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that in the overwhelming majority of cases, there was

a difference as to where the operator perceived the

arteriotomy site (PAPS) to be and where the arteri-

otomy site actually was (TAPS).

The practical, salient connotation of our observa-

tions is that TAPS is almost always caudad to PAPS.

In more than 80% of cases by an average of 4.4 mm,

TAPS is more caudally located than PAPS. An arte-

rial puncture site that most operators would currently

interpret as borderline high, above the inguinal liga-

ment (as determined by using the inferior epigastric

artery as a surrogate for the inguinal ligament), and

therefore possibly intrapelvic and not suitable for most

closure devices, may actually in 80% of patients be at

least 3 mm or more lower than perceived. In this sce-

nario, knowledge of the TAPS, as opposed to PAPS,

would allow for a safe deployment of a closure device,

without major risk for retroperitoneal hemorrhage.

Alternatively, an arterial puncture site that in the

minds of most operators appears to be just clearing

the CFA bifurcation on FSA and therefore perceived

suitable for any type of VCD may actually be in or

below the CFA bifurcation. In those cases, the use

of certain VCDs could result in device malfunction,

causing vessel occlusion, hematoma, or pseudoaneu-

rysm. This would be especially true for closure devices

like Angioseal (St. Jude Medical) and Perclose (Abbott

Vascular). Although some may consider an absolute

difference of 3 mm to 5 mm not very significant, this

difference may precipitate a change in management

of the arterial puncture site.

The optimal access point in the CFA has been a

matter of considerable research and debate and studies

by Yaganti et al10 and Pitta et al11 have demonstrated

that factors such as age, gender, body mass index,

and anatomy of the pelvis may impact the optimal

arteriotomy site. Thus the meaningful role of vascu-

lar ultrasound as a standard practice during vascular

access cannot be overlooked.12-15

STUDY LIMITATIONSAlthough our study was a nonrandomized retro-

spective analysis, readers were blinded during im-

age analysis. Also, interobserver variability may be a

potential problem.

CONCLUSIONSIn almost all cases, TAPS is caudad to PAPS. What

appears to the operator to be a borderline high ar-

terial puncture site posing a risk for retroperitoneal

hemorrhage, obviating safe use of an arteriotomy

closure device, may actually be a relatively benign

stick amenable to closure. Conversely, what appears

to be a borderline low arteriotomy, that just clears

the CFA bifurcation and therefore in the mind of the

operator suitable for any closure device may actually

be fraught with the hazard of complications with

certain types of VCDs like Angioseal and Perclose,

which are not entirely extravascular and traditionally

contraindicated in this situation.n

Editor’s note: Manuscript received January 15, 2015;

provisional acceptance given March 10, 2015; manuscript

accepted May 4, 2015.

Address for correspondence: Najam Wasty, MD, New-

ark Beth Israel Medical Center, Department of Cardiology

(C2), 201 Lyons Avenue, Newark, NJ 07112, United

States. Email: NWasty@barnabashealth.org

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