Evaluation of risk factors associated with femoral Pseudoaneurysms after cardiac catheterization

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Evaluation of risk factors associatedwith
femoral Pseudoaneurysms aftercardiac
catheterization
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• From the Departments of Cardiovascular Surgery
  and Radiology, Siyami Ersek Thoracic and
  Cardiovascular Surgery Center.

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Study Aim

• To evaluate factors associated with FPA of
  sufficient clinical significance that they
  required surgical treatment after diagnostic or
  interventional cardiac catheterisation.
• Specifically to assess if
• Diabetes mellitus
• Hypertension
• Elevated BMI
• High room catheterisation turnover
• Increasing catheter size
• Coronary artery disease
• Are independent risk factors for pseudoaneurysm
  requiring surgical repair

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Study population

• Case control study
• 41322 femoral catherisation procedures were done
  and 630 surgically managed femoral
  pseudoaneurysms developed. 36218 procedures were
  diagnostic and 5104 were interventional
• 30 cardiologists performing 250-300 cases per
  year in four catheterisation-laboratories
• Two controls were selected per patient matched
  for age, sex and catheterisation day.

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Methods

• Routine management
• If diagnostic
• No anticoagulation was given
• Introducer was removed at completion and 20
  minutes direct compression at insertion site by
  RMO/ physicians assistant, then sandbag
  compression for 2 hours and hospitalised for 8
  hours. Six French catheter as standard
• If interventional
• 300mg clopidogrel given to start then 75mg per
  day OR 10000 unit bolus of heparin followed by
  5000 units per hour
• Post procedure. introducer stabilized by suturing
  to the skin, then removed at 6 hours and follow
  the same pathway as for diagnostic
  catheterisation (except hospitalised overnight).
  Note 7 French catheter as standard

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Methods

• Femoral pseudoaneurysm was diagnosed with
  colour-flow Doppler, as was neck location and
  length.

• If the pseudoaneurysm was less than 5cm2 in 2
  dimensions or neck length 8mm

• If Pseudoaneurysm overall 2D size greater than
  5cm2 or neck lt8mm

Surgical correction (n 630)

• then it was managed by external compression
  (ultrasound-guided) and these results were
  excluded from the trial (n 85)

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Methods

• Surgical correction
• Also only Performed if
• Distal ischaemia
• Expanding haematoma
• New murmur
• Pulsatile mass
• Tenderness
• Marked pain
• Hypotension
• I.e. one of the above had to be present for
  surgical correction to go ahead.

• Surgical management
• Grafting (saphenous or prosthetic)
• Primary suturing
• Embolectomy

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Analysis

• SPSS software
• Pearson test
• Spearman test
• Stepwise backward logistic regression analysis

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Results

• Reasonable correlation for age and sex with
  controls
• Time for procedure
• 16 6 for diagnostic studies
• 37 12 for interventions
• Time until FPA diagnosed
• 2.1 0.7 days
• Likelihood of FPA requiring surgical repair
• 1.1 diagnostic procedures (n 398)
• 4.7 interventional procedures (n 232)
• Overall 1.5 (or 1.7 if all FPAs included)

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(No Transcript)
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Independent Risk factors

• Hypertension
• Odds ratio 1.52, CI 1.03-1.90 with (p 0.011)
• Diabetes Mellitus
• Odds ratio 1.11, CI 1.06 1.25 (p 0.035)
• Coronary artery disease
• Odds ratio 1.21, CI 1.05 -1.22 (p 0.022)

• Higher BMI
• Odds ratio 2.21(p lt 0.01)
• Larger Catheter diameter
• Odds ratio 2.39 (p lt 0.01)
• Elevated number of cases performed that day in
  the same room
• Odds ratio 2.82 (p lt0.01)

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In addition

• Numerically speaking
• BMI gt 28kg/m2
• gt 17 cases per room per day
• Use of a 7 French or larger sheath

• All were associated with higher pseudoaneurysm
  risk

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Results
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Discussion

• Increased numbers of arterial punctures being
  done and increased complexity of interventions ?
  increasing rate of pseudoaneurysm
• Prevention of FPA relies upon
• non-traumatic arterial puncture
• good post-operative compression
• use of closure devices

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Discussion

• Acknowledged that they failed to address the
  distinction between interventional and diagnostic
  catheterisations but dismissed its significance
• Felt that the increasing rate of FPA with
  increasing number of patients done per day had to
  do with the decreased compression time afforded
  by the faster turn over rate.

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Point given most emphasis

• Compression time was seen to be the most
  important factor in reducing the risk of Femoral
  pseudoaneurysm

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Appraisal

• Level 3, case-control study
• Selection bias is an inherent problem with the
  style of trial
• Hypothesis clear
• FPA incidence
• Other trials have ranges 0 141

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Appraisal

• Reference population Only those having
  catheterisation and developing an aneurysm worth
  surgically correcting
• It is made clear that they are focusing on the
  group of people whose pseudoaneurysms required
  surgical correction, but can you really
  distinguish risk factors for pseudoaneurysm from
  those of pseudoaneurysm requiring surgical
  repair? i.e. is exclusion of the 85 patients
  whose aneurysms were managed conservatively a
  bias?
• Indicators for surgical correction initially seem
  somewhat arbitrary but make some sense when you
  note that size and neck length are not all that
  determines the need for correction

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Selection bias

• No mention of failure rates for ultrasound-guided
  compression of pseudoaneurysm
• 63 88 success rate at most in other trials 1
• Failure ? surgery
• Likelihood of requiring surgical repair very high
  in this trial (88) usually 20-402
• Morgan and Belli trend towards reduced success
  with larger pseudoaneurysms but as much as 67
  success rate in individual trials with
  pseudoaneurysm 4-6cm in size.
• No relationship shown between neck length, age of
  patient, neck width, mulitloculation of
  pseudoaneurysm or chronicity.

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Selection bias

• Unclear how they chose people to ultrasound
• were all people given a Doppler ultrasound or
  only those with symptoms/ signs?
• No clinical parameters for diagnosis of
  pseudoaneurysm or surveillance for ultrasound
  referral.

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Confounders

• Confounding value for interventional v diagnostic
  procedures quantified as percentage 4.7 versus
  1.1 procedures.
• Widely recognized as an influence on the
  incidence1
• All interventional patients also received 10000
  unit heparin bolus and then 5000 units/hour
  EXCEPT in the last 2 years of the trial when
  300mg clopidogrel was given initially followed by
  75mg/day. Anticoagulation alone has been shown to
  increase incidence2
• The practice of suturing their introducers has
  not been shown to change the overall incidence of
  pseudoaneurysm or complications2
• Confounder of diagnostic v interventional
  recognized then not applied to processing of
  results.

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• No drop out rate, nor any defined length of time
  for follow-up outside of hospital
• Most patients had diagnostic procedures and thus
  would have been discharged from the cardiology
  service, if not the hospital
• No Power given for the results obtained
• Many of their conclusions have little to do with
  their results
• No audit of actual compression times therefore no
  evidence that compression time was important
• No use of closure devices (and the conclusion is
  contrary to major literary sources2)

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References

• Morgan R, Belli A-M, Current Treatment Methods
  for Post catheterization Pseudoaneurysms.
  Vascular Interventional Radiology 2003
  14697710
• Koreny M, Reidmuller E, Nikfardjam M, Siostrzonek
  P, Mullner M, Arterial puncture closure devices
  compared with standard manual compression after
  cardiac catheterisation Systematic review and
  meta-analysis. JAMA jan 21, 2004 vol 291 3
  350-357