Cases & Commentaries

Coming Undone: Failure of Closure Device

Commentary By Jose L. Baez-Escudero, MD; Glenn N. Levine, MD

The Case

A 65-year-old man underwent coronary angiography
because of atypical exertional chest pain and shortness of breath.
He was found to have coronary artery disease with significant
narrowing of the proximal left anterior descending artery and a
number of narrowings more distally. A bare metal stent was placed
in the proximal lesion. A number of attempts were made to place
more distal stents, but they could not be positioned correctly.
After the procedure, the femoral artery sheath was removed and
hemostasis was achieved with the use of an angio-seal closure
device. A cardiovascular surgeon was consulted that day, and bypass
surgery was scheduled for 4 days later.

The day after angiography, the patient, who was
now home, was active and playing with his visiting grandchildren.
The next day, the patient developed bleeding from the catheter site
in his groin. The bleeding was not stopped by local pressure, and
he returned to the hospital, where he was found to be tachycardic
and hypotensive. His hematocrit dropped from 42% to 36%, and a
computed tomography (CT) scan revealed a large (14 cm)
retroperitoneal hematoma. He was taken to the operating room, and
it was discovered the angio-seal closure device had failed and the
femoral artery puncture (arteriotomy) was repaired.

The patient subsequently had complications
related to the retroperitoneal hematoma, including persistent
fever, leukocytosis, ileus, and back pain. His coronary artery
bypass surgery was delayed, and while hospitalized waiting for the
procedure, he suffered a cardiac arrest and died.

The Commentary

Cardiac catheterization is a diagnostic procedure
that can be used to evaluate cardiac hemodynamics, ventricular
function, and coronary artery anatomy. The introduction of
percutaneous coronary intervention (PCI), including balloon
angioplasty and stenting, as a therapeutic adjunct to
catheterization has revolutionized the contemporary treatment of
cardiovascular disease. In 2004, the estimated number of inpatient
diagnostic catheterizations was 1,471,000, and the number of
inpatient PCI procedures was 1,285,000.(1) Adding outpatient diagnostic and therapeutic
catheterizations would significantly increase these numbers.

Diagnostic catheterization and PCI are associated
with a variety of adverse events, ranging from minor problems
without long-term sequelae to major complications requiring
immediate therapy. This case of a 65-year-old man—who
underwent coronary angiography and had a major complication that
required an unplanned vascular surgical repair, delayed his
necessary bypass surgery, and ultimately led to his
death—illustrates one of the complications of cardiac
catheterization and PCI. In the following discussion, the most
common complications of cardiac catheterization and measures to
prevent, diagnose, and treat these complications are reviewed.

The risk of a major complication (those
considered serious or life-threatening) during diagnostic cardiac
catheterization is less than 1%–2%. In one large series, the
multivariate predictors of major complications were cardiogenic
shock, acute myocardial infarction (MI), renal insufficiency,
cardiomyopathy, valvular disease, poorly compensated heart failure,
severe hypertension, and unstable angina.(2)

The rate of catheterization-related death has
declined steadily over the past 15 years and is now approximately
0.08%.(3) The
risk of death varies with age, as well as with the presence of the
clinical predictors mentioned above. Patients with severe narrowing
of the left main coronary artery and poor left ventricular function
(ejection fraction [EF] 2-4)

Embolization of thrombus, air, or atheromatous
debris is an important cause of periprocedural stroke and MI. The
rate of procedure-related stroke, one of the most devastating
complications of cardiac catheterization, was as high as 0.23% in
1973 (3) but
has decreased to 0.06% in contemporary registries.(5) The current risk rate for procedure-related MI is less
than 0.03%. Risk factors for suffering an acute MI during the
procedure include recent unstable angina or non–Q-wave
infarction, severe coronary artery disease, and the presence of
important comorbidities.(2-4)

Administration of radiocontrast agents used
during catheterization may cause complications such as allergic
reactions or renal failure. Reactions to the iodinated contrast
agents commonly used occur in approximately 1% of
patients.(6)
These result from direct complement activation and are classified
as anaphylactoid reactions. Symptoms include urticaria, angioedema,
bronchospasm, and hypotension. The risk is higher in patients with
other multiple allergies or history of a prior reaction to contrast
agents. To prevent allergic reactions, high-risk patients should be
premedicated with corticosteroids (usually prednisone administered
the night prior to and morning of the procedure) and a histamine
receptor blocker (diphenhydramine), and a nonionic contrast agent
should be used.(6,7)

Renal failure is one of the more common
complications of catheterization.(8)
Renal dysfunction can occur by several mechanisms, including direct
contrast-induced nephropathy, dehydration, renal atheroemboli, and
hypotension with renal hypoperfusion. Contrast-induced nephropathy
is likely the most common cause; it results in a transient rise in
the creatinine concentration of more than 1.0 mg/dL in at least 5%
of patients undergoing catheterization.(9) Patients with diabetes or preexisting renal
insufficiency carry the highest risk.(10) In the setting of contrast-induced nephropathy, the
creatinine usually begins to rise 24–48 hours after the
procedure, peaks within 3–5 days, and typically returns to
baseline within 7 days. Notably, fewer than 1% of patients with
contrast-induced renal dysfunction go on to require
hemodialysis.(10)
Strategies to prevent contrast nephropathy include administering
and maintaining adequate hydration, limiting the dose of contrast,
and possibly using agents such as acetylcysteine in high-risk
patients.(8,9)
(The topic of contrast-induced nephropathy was covered in a
previous WebM&M
commentary.)

This unfortunate case highlights one of the most
common complications of this widely performed procedure.
Retroperitoneal hematomas result from bleeding from the femoral
artery (which is cannulated during the procedure with a large
sheath) into the retroperitoneal space (Figure). The bleeding is typically from arterial
puncture above the inguinal ligament or inadequate hemostasis after
the procedure but may also occur spontaneously from the
anticoagulation used for PCI. Diagnostic catheterizations in the
past were typically performed after administration of variable
amounts of heparin. In current practice, many of these diagnostic
catheterizations are performed without administration of
anticoagulant therapy. Anticoagulant therapy used during PCI varies
depending on the operator and the clinical situation but can
include high doses of unfractionated heparin, enoxaparin, the
direct thrombin inhibitor bivalirudin (Angiomax), and platelet
glycoprotein IIb/IIIa inhibitors (potent antiplatelet agents). The
half-life of these agents varies from between 20 minutes to 12
hours or more. The major determinant of successful ultimate
hemostasis is the quality of the initial puncture, which depends
primarily on operator skill and experience. Typically, at the end
of cardiac catheterization, the sheath in the femoral artery is
removed, and hemostasis is achieved from one of several methods.
Manual compression of the artery is the traditional method and is
easy to perform, but it is associated with the longest period of
bed rest, considerable patient discomfort, and a low but definite
complication rate. Vascular closure devices (mechanical and
biochemical devices that help "seal" the artery) were developed in
an attempt to reduce bed rest time, improve patient comfort, and
perhaps lower the complication rate associated with manual
compression. However, their use may actually increase the risk of
local vascular complications with diagnostic catheterization and
PCI or the severity of such complications.(11) These depend upon the specific device used and
whether the procedure is a diagnostic catheterization or a PCI
(12),
as well as upon operator expertise. Closure devices may also
increase the risk of local infection or endarteritis. Decisions
regarding whether to use manual compression or a vascular closure
device, as well as which vascular closure device, are complex and
must weigh the location of the groin stick, patient body habitus,
anticoagulants used, and local expertise with a particular closure
device.

In this patient, given the delay in the
development of the hematoma, the likely cause of the bleeding was
failure of the closure device. Whatever its cause, the diagnosis of
retroperitoneal hematoma is initially made on clinical grounds.
Symptoms, signs, and laboratory abnormalities that should raise
suspicion of retroperitoneal bleed include hypotension, back or
flank pain, and an otherwise unexplained drop in hemoglobin. CT
scanning can be used to confirm the diagnosis. Retroperitoneal
bleeding is treated by aggressive volume resuscitation, correction
of coagulopathy, and blood transfusion. Surgery is rarely necessary
and is reserved for hypotension unresponsive to volume or for a
progressive drop in hemoglobin despite transfusion.(13)

Overall, vascular complications, including
retroperitoneal hematomas, account for the highest proportion of
complications in cardiac catheterization.(13) Other vascular complications may include acute
arterial thrombosis, distal embolization, dissection,
pseudoaneurysm, or arteriovenous fistula. A pseudoaneurysm occurs
when the arterial puncture site does not adequately seal and can
follow manual compression or use of a vascular closure device.
Findings suggestive of pseudoaneurysm at the puncture site include
pulsatile mass, extreme tenderness, or new bruit. Patients with
suspected pseudoaneurysm should undergo Doppler imaging. While
smaller pseudoaneurysms can often be managed conservatively, larger
pseudoaneurysms will usually be treated with ultrasound-guided
occlusion, thrombin injection, surgical repair, or other
interventions.

Cardiac catheterization is one of the most
commonly performed procedures in medical practice and has low
overall complication rates. However, numerous potential life- and
limb-threatening complications are possible. For the individual
patient, the risk of an adverse event is dependent upon
comorbidities, cardiovascular anatomy, demographics, experience of
the operator, and the type of procedure being performed. The
risk-to-benefit ratio usually favors performance of this procedure
as part of the evaluation and treatment of potentially fatal or
lifestyle-limiting cardiac disease in appropriately selected
patients. Physicians performing cardiac catheterization and those
caring for patients who have undergone the procedure must
understand the risk of complications and learn how to recognize and
treat them. While complications cannot be entirely eliminated,
their incidence can be reduced by careful patient selection,
preparation, and attention to detail.

Take-Home Points

  • Cardiac catheterization is a commonly
    performed procedure with relatively low overall rates of major and
    minor complications, but complications do occur and there should be
    a good clinical indication for the procedure.
  • Vascular complications are the most
    common, although other complications include procedure-associated
    stroke, MI, and contrast-induced renal failure.
  • Retroperitoneal hematomas can result
    from improper arterial puncture or failure to achieve adequate
    hemostasis after removal of the femoral artery sheath.
  • Arterial puncture closing devices do not
    necessarily decrease local vascular complications, and patients
    treated with these devices should undergo the same vigilant
    monitoring as those treated with manual compression.
  • Physicians caring for patients after the
    procedure should be aware of the common periprocedural
    complications.

Jose L. Baez-Escudero, MD
Fellow in Cardiovascular Disease, Department of
Medicine—Section of Cardiology
Baylor College of Medicine

Glenn N. Levine, MD
Associate Professor of Medicine, Baylor College of Medicine
Director, Cardiac Care Unit, Michael E. DeBakey Medical
Center

References

1. Rosamond W, Flegal K, Friday G, et al. Heart
disease and stroke statistics—2007 Update: a report from the
American Heart Association Statistics Committee and Stroke
Statistics subcommittee. Circulation. 2007;115:e69-e171. [go to PubMed]

2. Scanlon PJ, Faxon DP, Audet AM, et al. ACC/AHA
guidelines for coronary angiography: a report of the American
College of Cardiology/American Heart Association Task Force on
practice guidelines (Committee on Coronary Angiography): developed
in collaboration with the Society for Cardiac Angiography and
Interventions. J Am Coll Cardiol. 1999;33:1756-1824. [go to PubMed]

3. Johnson LW, Lozner EC, Johnson S, et al.
Coronary arteriography 1984-1987: a report of the Registry of the
Society for Cardiac Angiography and Interventions: I: results and
complications. Cathet Cardiovasc Diagn. 1989;17:5. [go to PubMed]

4. Laskey WK, Kimmel S, Krone RJ. Contemporary
trends in coronary intervention: a report from the Registry of the
Society for Cardiac Angiography and Interventions. Catheter
Cardiovasc Interv. 2000;49:19-22. [go to PubMed]

5. Segal AZ, Abernethy WB, Palacios IF, et al.
Stroke as a complication of cardiac catheterization: risk factors
and clinical features. Neurology. 2001;56:975. [go to PubMed]

6. Lasser EC, Berry CC, Talner LB, et al.
Pretreatment with corticosteroids to alleviate reactions to
intravenous contrast material. N Engl J Med. 1987;317:845-849.
[go to PubMed]

7. Wittbrodt ET, Spinler SA. Prevention of
anaphylactoid reactions in high-risk patients receiving
radiographic contrast media. Ann Pharmacother. 1994;28:236-241.
[go to PubMed]

8. Aspelin P, Aubry P, Fransson SG, et al.
Nephrotoxic effects in high-risk patients undergoing angiography. N
Engl J Med. 2003;348:491-499. [go to PubMed]

9. Gruberg L, Mintz GS, Mehran R, et al. The
prognostic implications of further renal function deterioration
within 48 h of interventional coronary procedures in patients with
pre-existent chronic renal insufficiency. J Am Coll Cardiol.
2000;36:1542. [go to PubMed]

10. Shyu KG, Cheng JJ, Kuan P. Acetylcysteine
protects against acute renal damage in patients with abnormal renal
function undergoing a coronary procedure. J Am Coll Cardiol.
2002;40:1383-1388. [go to PubMed]

11. Koreny M, Riedmuller E, Nikfardjam M, et al.
Arterial puncture closing devices compared with standard manual
compression after cardiac catheterization: systematic review and
meta-analysis. JAMA. 2004;291:350. [go to PubMed]

12. Nikolsky E, Mehran R, Halkin A, et al.
Vascular complications associated with arteriotomy closure devices
in patients undergoing percutaneous coronary procedures: a
meta-analysis. J Am Coll Cardiol. 2004;44:1200. [go to PubMed]

13. Levine GN, Kern MJ, Berger PB, et al.
Management of patients undergoing percutaneous coronary
revascularization. Ann Intern Med. 2003;139:123–136. [go to PubMed]

Figure

Figure. Retroperitoneal Bleeding from the
Femoral Artery. Illustration by Chris Gralapp.