Methodist Hospital is a 426-bed community and teaching hospital in St. Louis Park, Minnesota, a western suburb of Minneapolis, where more than 2000 catheterizations and 1000 interventional procedures are performed each year. The interventional cardiology department had noted a groin complication rate that, although average for the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR), was consistently at the trailing edge of that bar. Given the morbidity, mortality, costs and disruption associated with groin bleeds, a 2-year effort was undertaken on top of earlier initiatives to reduce these adverse events. The subsequent improvement brought Methodist Hospital to the leading edge of the average bar, a 60% reduction in bleeds. In the effort, earlier recognition and treatment of bleeds was also seen. The institution hopes to ultimately reduce bleeds by more than 90%. The list that follows annotates a number of issues, opportunities and requirements identified.
1. Groin bleeds are a major cause of morbidity and mortality associated with cardiac catheterization procedures and percutaneous coronary interventions.
2. Cardiologists and staff receive essentially no formal training on reducing groin bleeds and cardiologist and staff skills vary widely in techniques for preventing, recognizing, and managing groin bleeds.
3. Unless each cardiologist and staff member takes a zero tolerance attitude towards groin bleeds, preventable groin bleeds will continue to occur.
4. New care guidelines will eliminate CMS reimbursement for faulty care. Groin bleeds undoubtedly will make that list.
5. Groin bleeds and retroperitoneal hemorrhage can no longer be viewed as a rare, but necessary evil.
6. In almost every bleeding incident, a potentially preventable root cause as well as a missed opportunity for earlier recognition of bleeding and therapeutic intervention can be identified.
7. Reducing the incidence of groin bleeds as much as possible, plus improving their early recognition and prompt intervention are the key to optimal catheterization patient management. This represents a substantial opportunity for systematic care improvement.
8. Groin bleeds are not just addressed at the time of sheath removal or when a hematoma forms; they must be anticipated and steps taken to avoid them at each step of the catheterization procedure. The early signs of hemorrhage may be subtle and misinterpreted as a reaction to a nitrate or an unexpected vagal reaction during a case. Early recognition of a groin bleed requires attention to these often subtle, but common, clues.
9. Nurses must be trained to distinguish nuisance skin wound bleeding (very common in patients pretreated with clopidogrel, glycoprotein IIb-IIIa receptor inhibitors and low molecular weight heparins) from significant femoral vein or arterial bleeding and retroperitoneal hemorrhage. Standardized protocols for the management of nuisance bleeding, and evaluation and initial management of hematomas, including obtaining an ultrasound for possible pseudoaneurysm and providing an initial fluid bolus for a sustained, unexpected drop in blood pressure, will expedite staff response should serious bleeding become evident even while the physician is being contacted.
10. Systematic review of groin bleeds and retroperitoneal hemorrhage — the ‘Groin Group’
a. Members from Cath Lab, CCRN, CCU staff nurse, outpatient unit nurse, and step-down unit nurse
b. Selected input from interventional radiology and vascular surgery
c. Goal: 0% surgical groin bleeds. In aiming for that improvement transfusion, length of stay costs and mortality from bleeding complications will be reduced.
11. Systematic review can reduce major bleeding events by half.
a. Lessons learned become lessons lost if the review of complication is not timely, within 1-2 weeks
b. Every serious bleed should be reviewed in cath conference or otherwise disseminated among staff and physicians.
12. With such an approach, our lab has reduced groin bleeds by 60%. Our goal is 90%. When we started this process, we were ‘average,’ according to the American College of Cardiology database comparisons. We hope to eventually set the database standard.
13. Steps for prevention and early recognition of groin bleeds in all patients:
a. Identify the femoral head landmark for safe puncture attempt on fluoroscopy with a Kelly Clamp or other metal device.
b. Cine a right anterior oblique (RAO) and/or left anterior oblique (LAO) shot of the femoral arterial sheath in situ with 6-8 cc contrast whether or not a closure device is to be used (especially if there were any entry difficulties) — it is essentially standard practice for interventional radiologists to look at the arterial puncture. In a cardiac program wishing to reduce groin bleeds, filming that look might identify the problem upfront and leaves a record that can be reviewed if something unexpected happens. Interventional radiology physicians have virtually no bleeds, so there is a lot we can learn from them — it is rather cavalier for interventional cardiologists whose patients are routinely treated with heparin, clopidogrel, and glycoprotein receptor inhibitors to think they can get by with less attention to cannulation and decannulation, and not have their patients suffer the consequences. No matter how experienced an individual physician may be, standardizing the pre-procedure assessment of each groin will further reduce bleeds. Indeed, the problem is usually identifiable, and hence earlier recognition and management of the bleed may be facilitated by systematic review of these ‘boring’ little cine runs. We must train ourselves to systematically review the entire groin study, not just the sheath entry site or sheath relation to the common femoral-profunda bifurcation, inferior hypogastric artery or femoral head. Leaks tracking up along the femoral bundle can be subtle.
c. Learn the angiographic anatomy of the region: common femoral artery, profunda femoral artery, landmarks indicating ‘high’ (above inguinal ligament/above the inferior course of the inferior hypogastric artery) and ‘low’ sticks (at or below the bifurcation of the common femoral artery into the profunda and superficial branches) and what the complications of intramural sheath placement (sheath tracks within the femoral arterial wall for more than a few millimeters before entering the lumen), perforation, and pseudoaneurysm look and feel like. With error followed by analysis comes learning, and with shared learning comes improved outcomes.
d. The RAO projection is the usual preferred view because it lays out the bifurcation of the common femoral artery so that a low stick, the usual error, is identified easily. Also, if there is a hip prosthesis, it is the only view that allows you to see the artery. However, the LAO projection allows one to better see the entry of the sheath into the artery and makes it easier to see posterior wall perforations, which lay behind the artery in the RAO projection. The RAO view is obscured if a hip prosthesis is present.
14. Patients with coagulopathy:
a. Warfarin (International Normalized Ratio [INR] over 1.6) — use extra caution, special techniques, or approaches.
b. Warfarin (INR over 2.5) — consider fresh frozen plasma (FFP) over 4-6 hours or 1mg vitamin K intravenous (IV) 24 hours in advance of cath. For acute myocardial infarction with high INR, consider using a micropuncture technique, consider leaving the sheath in until the next morning or using a closure device, so you know whether or not you have hemostasis by the time you leave the lab.
c. Don’t do high bleeding risk cases unless there is no choice. Temporize and reduce coagulopathy.
e. Glycoprotein IIb/IIIa Receptor Inhibitors
f. Heparin or low-molecular-weight heparin (LMWH)
g. Direct thrombin inhibitors
i. Micropuncture technique
ii. Vascular ultrasound assisted access
i. Obviously ‘high’ sticks:
i. If you don’t routinely fluoroscope the groin, you will have more complications than if you look every time. Even those who ‘never miss’ do miss once in a while.
ii. If you don’t take a picture of the groin with contrast, you won’t know about some retroperitoneal bleeds until the patient is in shock.
iii. If you don’t carefully review each groin shot, you’ll still miss opportunities to reduce bleeding complications. If you review them again when a groin complication occurs, about half the time you’ll find something you missed and the next time you’ll do better.
j. Patients with access issues:
i. Morbidly obese:
1. Consider brachial or radial approach
2. Micropuncture technique
3. Vascular ultrasound-assisted access
ii. Patients with atherosclerosis of the ileo-femoral system:
1. Firm arteries with diminished pulse and calcification make puncture and sheath insertion more difficult. Hydrophilic coated sheaths, use of extra support wires and up-dilating from micropuncture to 4 Fr to 5 Fr may be helpful.
k. Bleed management:
i. Double or multiple puncture of artery and or veins — higher probability of bleeding with multiple sticks.
ii. Hematoma formation during case
1. Bleeding from around sheath: Upsize or closure device
2. Bleeding from double/multiple punctures: C-clamp with or without sheath removed, closure device, etc.
iii. Closure device failures:
1. Long hold
2. C-clamp — up to an hour or more — increased risk of cutaneous or deep femoral neuropathy.
3. Early discontinuation of glycoprotein receptor inhibitors.
iv. Post procedure hematomas:
1. If you don’t like the way the groin behaved:
a. Clamp it — or clamp it longer
b. Do an ultrasound (yes, in the lab with the patient on the table)
c. Determine whether there is a pseudoaneurysm or retroperitoneal bleeding before you have a large hematoma
d. Discuss the wayward groin with a cardiology colleague and/or interventional radiologist
e. Let your vascular surgeon know something is afoot
v. Post procedure hypotension:
1. Volume loss +/- vagal effects from pain in groin or pain in abdomen from retroperitoneal hematoma.
2. Sometimes it is the medications.
3. Get an EKG or echo if needed to rule out myocardial infarction.
4. Patients with belly pain and expanding abdomen with shock need a lot of fluid and sometimes some atropine.
5. Don’t let them succumb in the CT scanner looking for what you already know must be there.
6. Don’t forget cardiac tamponade as a possibility, especially if temporary pacer was used with glycoprotein receptor inhibitor/ heparin, or difficult stenting and significant dissection.
7. If tamponade is suspected, review films for missed perforation while an echo is being done. As soon as you see the effusion, tap it and leave a drain in; it may take 2-3 hours for the coagulopathy from heparin and glycoprotein receptor inhibitor to resolve. At that point, bleeding generally stops and the drain can be removed the next morning. Follow up echo an hour later, at the end of the day and prior to drain removal the next day can allay fears that blood has reaccumulated in the pericardium.