The incidence of major femoral arterial access bleeding, which includes hematomas > 5 cm, femoral bleeding requiring transfusions, and/or surgeries and retroperitoneal bleeds, has declined significantly due to various reasons (the adoption of default transradial access and ultrasound-guided arterial puncture and a significant reduction in the use of glycoprotein IIb/IIIa inhibitors). In the setting of acute coronary syndrome (ACS), major femoral bleeding is not only a strong predictor of 30-day mortality (OR 7.55), but also of composite ischemia, stent thrombosis, and one-year mortality (HR 3.5).1,2 In this Tip of the Month, we will summarize the prevention and management of major femoral bleeding following percutaneous coronary intervention (PCI).

Incidence of Major Femoral Bleeding in Contemporary PCI

The incidence of major access-site bleeding (Bleeding Academic and Research Consortium, or BARC 3 or 5) was 1.1 percent in patients with ACS undergoing a transfemoral PCI between 2011–2014.3 In patients with ST-segment elevation myocardial infarction (STEMI) undergoing a primary transfemoral PCI between 2011–2018, non-coronary artery bypass grafting (CABG) Thrombolysis in Myocardial Infarction (TIMI) major and BARC 3–5 bleeding was noted to be 2–2.3 percent.4 The incidence of vascular complications (including access-site bleeding) ranges from 2.47–6.4 percent with large bore (> 8F) access.5

Risk Factors for Major Femoral Bleeding6 (Table 1)

Variable

OR

Age > 75 years vs. age < 55

2.59 (1.94–3.45)

Use of post-procedure heparin

2.46 (2.09–2.91)

Severe renal impairment

2.25 (1.67–3.03)

Female gender

1.64 (1.39–1.94)

Log2 peak-activated clotting time

1.60 (1.27–2.03)

7–8F sheath size vs. < 6F

1.53 (1.29–1.83)

Glycoprotein IIb/IIIa inhibitor use

1.39 (1.19–1.63)

Logprocedure duration

1.20 (1.08–1.33)

 

Management of Major Femoral Bleeding

Femoral bleeding after a coronary angiography/PCI can rapidly become a life-threatening emergency. Prompt recognition and management is imperative.

Large Groin Hematomas

  1. If the sheath is still in place, upsize the sheath by one French size. If the hematoma continues to expand, remove the sheath and apply manual pressure, control hypertension, and consider deploying a suture-mediated closure device like Perclose (Abbott Laboratories, Abbott Park, Illinois) with wire protection. Consider a compression device like FemoStop (St. Jude Medical, Minnetonka, MN) for prolonged compression.
  2. If the sheath has been removed, ensure manual pressure is applied proximal to the puncture site such that the artery is compressed against the femoral head. Hold occlusive pressure for at least 10 minutes and then reassess. If bleeding is controlled, continue holding moderate pressure for an additional 15–20 minutes. Provide adequate pain control.
  3. If the hematoma continues to expand or rebleeding occurs after the release of manual compression, notify vascular surgery. An expansile femoral artery strongly suggests a pseudoaneurysm, which may require urgent surgical intervention or ultrasound-guided thrombin injection.
  4. Monitor blood pressure closely. If hypotension develops, treat aggressively to prevent a downward spiral. Give a fluid bolus; obtain central venous access; type and crossmatch blood; and start a transfusion immediately, if needed with trauma blood protocol. Reverse anticoagulation, if possible.
  5. Consider femoral angiography and balloon tamponade/covered stent placement from radial or contralateral access if local expertise is present. If absent, notify vascular surgery, if not already done.
  6. Do not transport a hypotensive patient to the CT scanner. Correct hypotension and control bleeding before transport and accompany the patient by holding manual pressure to the CT scanner.
  7. Obtain a vascular ultrasound in patients with femoral hematomas to ensure the absence of a significant pseudoaneurysm before discharge, particularly if a new femoral bruit is heard.
  8. Educate patients on prevention and signs of femoral bleeding, especially patients discharged on oral anticoagulation, triple therapy, and those who live far from the hospital.

Management of Retroperitoneal Bleeding

Retroperitoneal bleeding is managed by fluid resuscitation, blood product administration, and close observation in the intensive care unit (ICU) setting. Patients usually stop bleeding due to the tamponade of the bleeding source by the accumulated blood. If bleeding does not stop, as manifested by the decline in hematocrit despite transfusion and/or hemodynamic instability, immediately involve vascular surgery or interventional radiology. Surgical intervention is indicated in cases where endovascular intervention fails/is unavailable and hemodynamic instability continues. Other indications for surgical intervention are abdominal compartment syndrome and the development of femoral neuropathy.

Quality Measures for Prevention of Major Femoral Bleeding

  1. Use radial instead of femoral access for PCI, if possible, especially in patients at high risk of bleeding, including ACS. In the RIVAL trial, transradial PCI was associated with a 64% reduction in access-site bleeding (ACUITY trial definition) compared with transfemoral PCI in patients with both non-STEMI and STEMI.7
  2. Use best practices for femoral access, most importantly ultrasound-guided femoral access, which includes the use of a micropuncture set (Cook Medical Inc., Bloomington, Indiana), ultrasound, and fluoroscopy. Ultra-sound guided femoral access appears to have comparable rates of major bleeding and vascular complications to radial access.8–10 Use ultrasound for every femoral access to become proficient.
  3. Perform a pre-PCI femoral angiogram, ideally via a micropuncture sheath or its dilator (with care to withdraw the tip from the arterial wall to prevent dissection), to ensure an optimal location of access before administering anticoagulation. If the entry site is suboptimal (high/low), the micropuncture dilator is removed, pressure is applied for five minutes, and then access is obtained again. This is especially of value before upsizing to a large bore sheath, such as for mechanical circulatory support.
  4. Use a meticulous technique for manual compression. Ensure optimal blood pressure control, an activated clotting time < 170 seconds, and an adequate duration of manual compression (sheath size multiplied by three minutes) with good technique. Some vascular closure devices may lower the incidence of vascular complications compared with manual compression.11
  5. Communicate with holding room staff if issues associated with a high risk of access-site bleeding with manual compression are present, such as a high- or low-stick, severely calcified vessel or significant abdominal pannus. Ensure handoff and communication among the cath lab room, holding room, and floor/ICU in a patient with femoral bleeding, as rebleeding is common and preventable.
  6. Develop critical care pathways for the management of major femoral bleeding and run mock drills with holding room and step-down staff.
  7. Educate staff, especially new personnel, step-down nurses, and floor nurses, on the correct manual compression technique. Assess established staff to ensure adequate technique.
  8. Use bleeding risk calculators for prediction of bleeding. Proactively take steps to prevent MFB in high-risk patients, such as preferentially using radial instead of femoral access for PCI (even for post CABG patients), and consider using bivalirudin instead of heparin if trans-femoral PCI has to be performed.
  9. Monitor PCI in-hospital, risk-standardized bleeding and perform a root-cause analysis if rates are higher than the 50th percentile of the national rate

Conclusion

Major femoral bleeding following PCI is strongly associated with blood transfusion; the prolongation of a hospital stay; and, most importantly, an increased 30-day and long-term mortality. Quality measures, as described above, are effective in the prevention and management of femoral access bleeding and can significantly lower morbidity and mortality.

 

References

  1. Manoukian SV, Feit F, Mehran R, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1362–8.
  2. Mehran R, Pocock SJ, Stone GW, et al. Associations of major bleeding and myocardial infarction with the incidence and timing of mortality in patients presenting with non-ST-elevation acute coronary syndromes: a risk model from the ACUITY trial. Eur Heart J. 2009 Jun;30(12):1457–66. 
  3. Valgimigli M, Frigoli E, Leonardi S, et al; MATRIX Investigators. Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial. Lancet. 2018 Sep 8;392(10150):835–848. 
  4. Le May M, Wells G, So D, et al. Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial. JAMA Cardiol.2020 Feb 1;5(2):126–134.
  5. Vetrovec GW, Kaki A, Dahle TG. A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention. Heart International. 2020;14(2):92–99.
  6. Doyle BJ, Ting HH, Bell MR, et al. Major femoral bleeding complications after percutaneous coronary intervention: incidence, predictors, and impact on long-term survival among 17,901 patients treated at the Mayo Clinic from 1994 to 2005. JACC Cardiovasc Interv. 2008 Apr;1(2):202–9.
  7. Mehta SR, Jolly SS, Cairns J, et al; RIVAL Investigators. Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation. J Am Coll Cardiol. 2012 Dec 18;60(24):2490–9. 
  8. Naidu SS, Abbott JD, Bagai J, et al. SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):255–276.
  9. Shroff A, Pinto D. Vascular Access, Management, and Closure: Best Practices. Accessed: August 12, 2020, https://scai.org/vascular-access-and-closure.
  10. Koshy LM, Aberle LH, Krucoff MW, et al. Comparison of Radial Access, Guided Femoral Access, and Non-Guided Femoral Access Among Women Undergoing Percutaneous Coronary Intervention. J Invasive Cardiol. 2018 Jan;30(1):18–22. 
  11. Vaitkus PT. A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention. J. Invasive Cardiol. 2004 May;16(5):243–6.