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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
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