Augustin AC, Quadros AS, Sarmentoleite RS, Gottschall CAM'

1
EARLY AMBULATION AFTER PCI A RANDOMIZED CLINICAL
TRIAL COMPARING IMMEDIATE VERSUS CONVENTIONAL
FEMORAL SHEATH REMOVAL

• Augustin AC, Quadros AS, Sarmento-leite RS,
  Gottschall CAM.

METHODS

• The prolonged bed rest after a percutaneous
  coronary intervention (PCI) by the femoral
  approach is one of the principal causes of
  discomfort for the patients.
• Several modifications in the techniques and
  adjunctive pharmacology during PCI took place
  since its beginning in 1977, but the handling of
  the sheath removal remains almost unchanged.
• Immediate sheath removal and early deambulation
  after PCI by femoral approach has been suggested,
  but clinical trials analyzing this strategy were
  not carried out.

• Study Design Randomized clinical trial
• Inclusion Criteria Patients submitted to PCI by
  femoral approach with a 6 french sheath at the
  Instituto de Cardiologia do Rio Grande do Sul,
  Porto Alegre-Brazil.
• Exclusion Criteria Patients in use of IIb/IIIa
  inhibitors, low molecular weight heparin and
  thrombolytics agents.
• Randomization Patients were randomized by a
  computerized software.

BACKGROUND

• Intervention Group The sheath was withdrawn
  immediately after the end of the ICP, when manual
  compression carried out for at least 20 minutes.
  If necessary, a mechanical compressor was used.
  In the patients with ACT gt 350 seconds, a period
  of 90 minutes were waited and then the sheath was
  removed. The patient was released for
  deambulation 3 hours after the end of the
  compression.
• Control Group The sheath was withdrawn according
  to the routine of the cath lab, 4 to 6 hours
  after the end of the PCI. Manual compression was
  carried out up bleeding stop and, if necessary,
  the patient was maintained under mechanical
  compression. The deambulation was carried out 6
  hours later.

OBJCTIVES

• To evaluate safety of the immediate
  removal of the arterial
• sheath and early deambulation after PCI.

RESULTS

• Patient Follow up The patients were kept for
  observation in the hospital for at least twelve
  hours after the procedures and evaluated for the
  presence of bleeding or hematomas before hospital
  discharge. Patients were instructed the return or
  get in touch with the attending physician or
  investigators in case of abnormalities in the
  puncture site.
• Primary endpoints
• Bleeding at the entry site
• Hematomas gt 5cm
• Pseudoaneurism
• Secondary endpoints
• Hematomas lt5cm
• Pain
• Urinary retention

• The study sample size was calculated considering
  a total bleeding rate of 10, plt0,05 and a a
  power of 80 (n442)
• T test, qui square or Fischer test were used
  for comparisons.

CONCLUSIONS

• The immediately femoral artery sheath removal and
  early deambulation after PCI was not associated
  with an increase in major vascular complications.
  
• It was related to a higher perception of comfort
  and small amount of small and clinical
  insignificant hematomas.
• This strategy can become an important alternative
  for patients with difficulties to remain in
  prolonged bed rest.

Institute of Cardiology of Rio Grande do Sul /
Universitary Foundation of Cardiology. Porto
Alegre, Brazil.