Excellent femoral outcomes when all access attempts and closure devices are performed by experienced cardiologists

doi:10.4236/wjcd.2013.39089

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World Journal of Cardiovascular Diseases, 2013, 3, 569-572 WJCD

http://dx.doi.org/10.4236/wjcd.2013.39089 Published Online December 2013 (http://www.scirp.org/journal/wjcd/)

Excellent femoral outcomes when all access attempts and

closure devices are performed by experienced cardiologists

Kevin S. Kang, Quentin Orlando, Robert Maholic, Richard Petrella, Gurjaipal S. Kang*

UPMC Hamot Hospital, Erie, USA

Email: *[email protected]

Received 25 September 2013; revised 27 October 2013; accepted 16 November 2013

which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Femoral access is considered less safe for access site

complications than the radial access. Cardiovascular

procedures have not been studied taking operator

experience, defined as American Board of Internal

Medicine, Interventional Cardiology certification or

equivalent qualification in another country, into ac-

count. We hypothesize that the procedural results are

operator dependent and excellent results are obtained

when procedures are performed by experienced op-

erators. Femoral access is higher risk than radial ac-

cess based on American College of Cardiology (ACC)

guidelines. Femoral access is less forgiving, as oppos-

ed to radial, as it is an end-artery, lacks easy com-

pressibility and is more likely to cause morbidity

when injured. Hence, radial is recommended over the

femoral approach according to ACC practice guide-

lines. These guidelines are often based on the rando-

mized studies from academic centers where trainees,

with variable arterial access experience, perform the

initial access stick and arterial closure device deploy-

ment. Methods: We performed a single center retro-

spective review of 32,446 consecutive patients under-

going invasive cardiovascular procedures done from

the femoral approach using American College of

Cardiology/National Cardiovascular Data Registry

(ACC/NCDR) from January 1, 2006 to June 30, 2013.

Only experienced operators performed the actual ac-

cess site stick and the reminder of the invasive pro-

cedure. Results: Total bleeding and vascular compli-

cations were less than 1%. We define outcomes as ex-

cellent if the total bleeding and vascular complication

risk is less than 1% based on previous studies dis-

cussed in the ACC guidelines. Conclusion: Excellent

outcomes can be obtained from the femoral access if

experienced cardiologists perform the procedure.

Hence, radial arterial access over the femoral access

may be selectively rather than universally recom-

mended considering the possibility of varying level of

femoral access expertise of different practices.

Keywords: Operators; Access; Complications

1. INTRODUCTION

Cardiac diagnostic and interventional procedures have

historically been performed using femoral arterial access

[1]. Associated risks include access site bleeding and

major vascular complications [2]. Radial access is favor-

ed to decrease the vascular complication risk during

these cardiovascular procedures [3,4]. However, there

are also some limitations pertaining to the radial artery. It

is associated with an increased radiation exposure to the

operator [5] and a higher risk of procedural failure due to

the smaller size and tortuous nature of the vessel [6]. It

may be harder to palpate the vessel in hypotensive pa-

tients and impossible to use with large diameter devices.

The American College of Cardiology (ACC) guidelines

increasingly recommend the use of the radial approach

[4]. The ACC guidelines are based on studies done ex-

clusively at academic centers where often a trainee, in-

stead of a board certified interventional cardiologist,

sticks the access artery and performs the closure device

procedure. These studies comparing femoral and radial

accesses fail to take the operator experience into account

when reporting outcomes [3]. We defined an experienced

operator as a board certified interventional cardiologist

because of three reasons. Firstly, a board certified cardio-

logist on average is more likely to have performed grea-

ter number of proc edures compared to a trainee. Second-

ly, the board certified attending cardiologist assumes full

responsibility of patient outcomes as opposed to trainees

or other staff where the ultimate responsibility still re-

sides with the attending cardiologists in the training pro-

gram. Also, board certification assures a complete know-

*Corresponding author.

OPEN ACCESS

K. S. Kang et al. / World Journal of Cardiovascular Diseases 3 (2013) 569-572

570

ledge base of invasive cardiovascular procedures. For the

purpose of our study, we define an excellent outcome as

a complication risk of less than 1%. We chose a number

of less than 1% total vascular complication risk as an

indicator on an excellent outcome based on the prior re-

sults from radial access studies and guideline recom-

mendations [3,4]. Coronary and carotid stenting pro-

cedures are dependent on operator volume [7,8]. We hy-

pothesize that any invasive cardiovascular procedure is

operator dependent and excellent results are possible

with femoral access when conducted by experienced

operators. The prior randomized studies may have favor-

ed the radial approach because the arterial access was

obtained by the trainees in academic centers where such

studies were conducted. This lack of experience of a

trainee may be associated with arterial injury to radial or

the femoral artery, leading to further complications and

less than excellent outcomes. We define arterial injury as

causing arterial dissection, perforation or emboli during

the course of access or closure device placement. How-

ever, such vascular injuries in the case of radial artery

may be asymptomatic. This is because the radial artery

access may be a forgiving approach to cardiac inter-

ventional and diagnostic procedures because it is super-

ficial, easily compressible and is not an end artery [9]. If

a trainee with minimal experience in arterial access in-

jures the radial artery, the clinical outcomes are not

likely to be affected. However, a femoral arterial injury

is more likely to result in symptomatic post procedure se-

quel, such as severe bleeding or ischemic complications.

Femoral artery is an end artery and is not easily com-

pressible for hemostasis. Prior studies comparing the two

access sites have favored radial over femoral without

accounting for operator experience [3]. If an injury, such

as dissection, of the femoral artery is avoided, the vas-

cular outcomes with femoral artery access should be ex-

cellent. Operator experience may be important in avoi-

ding femoral artery injury. Femoral artery may be prefer-

red in several settings because of its larger diameter, fre-

quent lack of tortuosity and easier palpation in hypo-

tensive patients [9]. When experienced operators conduct

femoral access procedures, total bleeding and vascular

complications may be less than 1%. The training level of

the operator can greatly mitigate the bleeding and groin

complication risks in patients undergoing femoral ap-

proach invasive procedures [7,8].

2. METHODS

All patients, presenting between January 1, 2006 and

June 30, 2013, that underwent an invasive cardiovascular

procedure through femoral access were included in our

study. The total number of consecutive patients who

were accessed via the femoral artery was 32,446. A

board certified interventiona l cardiologist does all patient

arterial access in our institution and the study was

exclusively done at our institution. The data reported in

this study is taken from the American College of Car-

diology/National Cardiovascular Data Registry (ACC/

NCDR). The NCDR Registry is an initiative of the

American College of Cardiology (ACC) and the Society

for Cardiovascular Angiography and Interventions and

has been previously described [10]. ACC committee pro-

spectively defined the variables, which are available at

www.ncdr.com (AUGUST 2013). The ACC/ NCDR has

specific definitions for endpoints such as bleeding,

dissection, emboli, fistula and pseudo-aneurysm, and

such definitions are available on the website and are

summarized below. Bleeding Complication: Blood loss

at the site of arterial or venous access, or due to per-

foration of a traversed artery or vein requiring transfu-

sion and/or prolonging the hospital stay, and/or causing a

drop in hemoglobin of >3.0 g/dL. Bleeding attributable

to the vascular site could be retroperitoneal (retroperi-

toneal bleeding), a local hematoma >10 cm with femoral

access, >2 cm with radial access, or >5 cm with bra-

chial access (hematoma bleeding), or external (entry site

bleeding). Vascular Complication: This category in-

cluded the presence of any one of the following vascu lar

complications pertaining to the percutaneous access site:

occlusion, defined as total obstruction of the artery by

thrombus, usually at the site of access requiring surgical

repair; embolization, defined as loss of distal pulse, pain

and/or discoloration (especially the toes); dissection, de-

fined as a disruption of an arterial wall resulting in split-

ting and separation of the intimal (subintimal) layers;

pseudoaneurysm, defined as the occurrence of a disrup-

tion and dilation of the arterial wall without identifi-

cation of the arterial wall layers at the site o f the catheter

entry demonstrated by arteriography or ultrasound; or

AV fistula, defined as a connection between the access

artery and the accompanying vein demonstrated by

arteriography o r ultrasound and most often characterized

by a continuous bruit. Bleeding or Vascular Complica-

tion: Either one or the other, or both. For the purpose of

our study, we use the NCDR/ACC registry limited to

data reported from our single institution. The study data

is limited to our center where only the nursing staff,

trained in the NCDR registry, is allowed to enter data.

These nurses have no financial affiliation with the opera-

tors. Our institution is a private, non-teaching hospital

and all operators who stick the arterial access site are

board certified interventional cardiologists rather than

cardiology fellows or other non-physician staff. The

study was limited to patients undergoing invasive cardio-

vascular procedures through femoral arterial access over

a 6 1/2 year period. No patients were excluded from this

group. Attempts are not made to directly compare this

K. S. Kang et al. / World Journal of Cardiovascular Diseases 3 (2013) 569-572 571

study with previous studies using statistical means be-

cause of differences in patient populations involved in

previous studies ev en though this is possible.

3. RESULTS

Patients selected for our single-center retrospective re-

view had inpatient follow up as required by NCDR [10].

32,446 patients were selected from January 1, 2006 to

June 30, 2013 with no exclusion criteria except for un-

dergoing invasive cardiovascular procedure from femoral

access. Greater than 50% of the femoral access patients

had Perclose or Starclose Closure Device deployment in

the end. Only board certified cardiologists were allowed

to attempt arterial access and closure device deployment

at our center. Our results reveal that there was low mor-

tality (<0.9%) in this large patient population undergo-

ing femoral access by experienced operators. Vascular

complications recorded were limited to bleeding (0.6%),

dissections (0.1%), occlusions (0.0%), pseudo-aneury-

sms (0.1%), emboli (0.0%) and fistulae (0.0%). The

overall risk of vascular complications with femoral ac-

cess was less than 1% and numerically lower than the

risk reported in previous studies [3]. The largest rando-

mized study, RIVAL, that compared the two access sites

reported vascular complications for radial access at 1.4%

and femoral access at 3.4% [3]. The complication risk in

our study involving femoral access patients was less than

1%. In our study, the patients were noted to have no

femoral infections. Table 1 lists values for bleeding and

vascular complications.

4. DISCUSSION

ACC/AHA guidelines advocate radial access over the

femoral access to reduce the vascular complication risk

[4]. A lot of prior data in the radial versus femoral litera-

ture has been collected from teaching hospitals where

Table 1. Complications of invasive procedures done from

the femoral access.

Total invasive femoral access procedures 32,446

Mortality 0.9%

Bleeding 0.6%

Dissection 0.1%

Occlusion 0.0%

Pseudoaneurysm 0.1%

Emboli 0.0%

Fistulae 0.0%

Total Bleeding and Vascular Complications 0.8%

trainees with minimal experience may attempt arterial

access and closure devices under the supervision of ex-

perienced cardiologists. The trainees may perform the

actual arterial access stick. The impact of trainees in get-

ting arterial access for cardiovascular procedures has not

been studied, to our knowledge, but in other specialties,

such as general surgery, the effect of trainees may in-

crease the complication risk [11]. Major studies compar-

ing outcomes with different types of arterial access were

done in teaching hospitals where trainees often get arte-

rial access and perform part of the invasive procedure

albeit under supervision [3]. The ACC/AHA guidelines

are based on such studies and recommend radial access

[4]. The guidelines are then applied to all types of prac-

tice patterns regardless of the training experience of the

operators. We realized that major studies like RIVAL

may not apply to our hospital. Our institution is unique

because only board certified cardiologists perform all

invasive procedure and closure devices. We decided to

look exclusively at our own hospital data so we could

learn more about the femoral vascular complication re-

sults in cardiology practices similar to ours where only

experienced operators performed the procedures. As far

as we know, similar data have not been published before.

In addition to access site complications associated with

operator experience, closure device complications may

also be operator dependent. The previously published

studies often had trainees placing closure devices possi-

bly leading to higher risk of vascular femoral site com-

plications. So, we expect that the overall vascular out-

comes associated with femoral access may be dependent

on the initial access stick and the final closure device

technique. Our results as noted above confirm our excel-

lent outcomes with femoral approach in an especially

high-risk population. The excellent outcomes of <1%

complication risk in our study, as predicted, may be due

to differences in the operator skill. Our operators were

board certified interventional cardiologists and no train-

ees or other non-physician staff was allowed to stick or

close the artery. Our study demonstrates that when only

board certified cardiologists perform access arterial stick,

the injury to the femoral artery may be decreased and as

a consequence, vascular and bleeding outcomes are ex-

cellent.

5. LIMITATIONS

Retrospective nature of the study and based in only one

center.

6. CONCLUSION

We conclude that if only experienced operators stick an

access site and personally perform the entire procedure,

excellent outcomes in patients with femoral access are

K. S. Kang et al. / World Journal of Cardiovascular Diseases 3 (2013) 569-572

572

possible. Our recommendation would not generalize the

clinical trial results from training centers to every cardi-

ology practice worldwide and endorse radial over the

femoral approach but acknowledge differences between

practices’ expertise in a particular access site.

OPEN ACCESS

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ABBREVIATIONS

ACC: American College of Cardiology

NCDR: National Cardiovascular Data Registry