Low Incidence of Bleeding Using the FemoStop® in Conjunction with Aggressive Quality Improvement Management

Presently, in many laboratories, the anticoagulant of choice in PCI is unfractionated heparin (UFH). Heparin inhibits reactions that lead to the clotting of blood in the coagulation cascade. In combination with antithrombin III (heparin cofactor), it can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. It also prevents the conversion of fibrinogen to fibrin, as well as preventing the formation of a stable fibrin clot. There is mounting evidence that heparin-platelet interactions affect PCI outcomes. Heparin actually increases platelet activation.³ Glycoprotein IIb/IIIa (GP IIb/IIIa) drugs block platelet aggregation, but not platelet activation.⁴ Platelet activation by UFH is a rationale for concomitant use of GP IIb/IIIa inhibitors and heparin. In addition to its action on fibrinogen, thrombin promotes activity of the clotting cascade, specifically factors V and VIII, intensifying clotting. In contrast, bivalirudin, a direct thrombin inhibitor, does not affect platelet activity directly, but does so via thrombin inhibition, both soluble and fibrin-bound, inhibiting the thrombin receptor on platelets. Bivalirudin prevents the conversion of prothrombin to thrombin through inhibition of thrombin-induced amplification of the coagulation cascade. Bivalirudin also has a short half-life. In theory, because bivalirudin does not activate platelets, practice may evolve to where concomitant use of a GP IIb/IIIa inhibitor would not be required. The absence of GP IIb/IIIa inhibition may lead to less bleeding. High levels of anticoagulation are a major cause of bleeding during and after PCI. In the EPIC (Evaluation of c7E3 for Prevention of Ischemic Complications) study, 2,099 patients were randomized to one of three arms: bolus and infusion of abciximab, bolus of abciximab and infusion of placebo, or bolus and infusion of placebo. The abciximab bolus and infusion arm, combined with heparin, significantly decreased new clot formation in PCI patients, but increased bleeding complications. In this study, any economic savings gained via a decrease in ischemic events or revascularization was lost to bleeding complications, most commonly from the access site.⁵ EPILOG (Evaluation in PTCA to Improve Long-term Outcome with ReoPro GP IIb/IIIa blockage), a follow-up study of 2792 patients, showed that by adjusting the dose of heparin based on weight while using the same dose of abciximab, bleeding complications post procedure were reduced without increasing the occurrence of ischemic events.⁶ The decreased incidence of post procedure bleeding offset some of the cost of drug therapy. The REPLACE-2 study was a trial designed to determine whether bivalirudin plus provisional use of GP IIb/IIIa could produce results equal or superior to the gold standard of GP IIb/IIIa plus heparin. REPLACE-2 randomized 6,010 patients in nine countries between October 2001 and August 2002. Lincoff, et al.² designed REPLACE-2 as a randomized, double-blind trial in which patients received a bivalirudin bolus followed by infusion for the duration of the procedure with provisional use of GP IIb/IIIa blockade or intravenous heparin (weight-based) accompanied by planned use of GP IIb/IIIa drug. The interventional operator had to specify use of abciximab or eptifibatide prior to randomization. REPLACE-2 demonstrated a significant reduction in major in-hospital bleeding rates from 4.1% to 2.4% (p 7 Data from trials using both UFH and bivalirudin demonstrate that post-PCI bleeding has clinical and economic impact on outcomes. The bivalirudin trials suggest that choice of anticoagulant may have an important role in reducing these events. Lower costs are attributable to the cost of bivalirudin versus GP IIb/IIIa medications and decreased rate of bleeding complications.¹ Management of post-PCI bleeding must take a high priority in quality patient management. Unit-Based Quality Improvement (QI) Initiative Recognizing the importance of bleeding management after PCI, we developed a major QI initiative to optimize bleeding outcomes based on appropriate management of sheath removal. Our QI initiative begins with intensive training of the staff. Per hospital policy (Penn-Presbyterian, internal document), staff qualified to remove arterial and venous sheaths includes cath lab nurses, technologists and cardiac care unit (CCU) nurses. Patients and their families are educated about the sheath-pulling procedure. Local infiltration of subcutaneous lidocaine 2% for local anesthesia decreases discomfort associated with the procedure. Sedation, usually midazolam and fentanyl, reduces pain and anxiety. Following PCI, we transfer the patient to either the CCU or post-PCI unit, based on patient acuity. We obtain hemostasis using the FemoStop® Femoral Compression System (Radi Medical Systems, Inc., Wilmington, MA). We collaborated with Radi Medical Systems to optimize sheath removal techniques. The FemoStop package consists of a belt and a pneumatic compression device. We place the belt under the patient’s hips, aligned with the puncture site, and position the compression device 1 cm superior and medial to the actual puncture site to focus maximum pressure over the insertion site into the femoral artery and vein. We then tighten the belt for a snug fit around the patient’s hips, maintaining the arch of the device in a level position. Removal of the arterial sheath is first, following aspiration of at least 5mL blood to prevent thrombo-embolization. The patient is encouraged to breathe slowly, through the mouth, to decrease tightening of the abdominal muscles, which makes hemostasis difficult. Arterial sheath removal occurs during exhalation, to further ensure that the patient cannot bear down, increasing the chance of vasovagal response and poor hemostasis control. During arterial sheath removal, we inflate the compression device, obliterating the distal pulse for 3-5 minutes, or until hemostasis occurs. Following this time interval, we lower the pressure on the device 20-30mmHg every 2-3 minutes (this is the interval of vital signs). When the pressure of the device is 20mmHg below systolic pressure, we remove the venous sheath following aspiration of 5mL blood to prevent thrombo-embolization. While maintaining adequate hemostasis, we decrease the pressure on the device to 40mmHg. The staff removing the sheaths remains with the patient during the entire procedure. Monitoring of the distal extremity is through presence of dorsalis pedis and posterior tibialis pulses as compared with pre-procedural baseline. We also monitor the temperature and color of the extremities as well as heart rate, blood pressure and pulse oximetry during the procedure, with vital signs recorded with each decrement in pressure on the FemoStop device. The pressure on the device remains at 40mmHg for the duration of the FemoStop application. The instrumented leg remains straight for 4 hours with low-pressure FemoStop application, and the patient remains on bed rest overnight. We perform neurovascular checks after sheath removal every 15 minutes x 4, then every 30 minutes x 4, then hourly until FemoStop removal. A trained cath lab nurse follows all PCI patients. Data collected for QI include mortality, Q-wave MI, congestive heart failure (CHF), emergent bypass surgery, cardiovascular accident (CVA), transient ischemic attack (TIA), major vascular complications, minor vascular complications, anaphylactic reactions, tamponade, renal failure, non-Q MI, and sub-acute stent thrombosis. Follow-up methods after sheath removal include direct observation of femoral site the following day, and consist of palpation of site for hematoma or tenderness, monitoring lab work, auscultation for bruit, and chart review. Clinical support by Radi Medical Systems includes on-site visits to the cath lab for continuing education, assistance in training new staff members, inservices for CCU and PCI unit nurses, as well as inservices for the cardiac med-surg nurses. Discussion of Results The cath lab director holds monthly meetings to discuss issues pertaining to the operation of the lab, including data collected on all invasive cardiac procedures. Those present at the meeting include the nurse manager, director of cardiac services, a clinical cardiologist, the former cath lab director, staff collecting data for both diagnostic and interventional procedures, and a staff physician from the cath lab. All complications discussed include type of complication, impact on length of stay, treatment necessary for the complication, if any, procedural physician, and whether we are maintaining a complication rate less than the American College of Cardiology (ACC) benchmark. The director of the cath lab is responsible for feedback to the physicians regarding their complication rate. Definition of Cath Lab QI Plan Our QI plan, effective 2002, focuses on five steps ensuring good outcomes. 1) Identify the problem. Both medical and nursing staff in the lab felt that the complication rate following sheath removal could be reduced using an alternative method of hemostasis. The C-clamp method of hemostasis had been the standard in our lab. The C-clamp caused discomfort to the patient and was difficult to position in an obese patient. 2) Initiate a plan. Cath lab staff participated in writing the policy and procedure for sheath removal for the Clinical Policy and Procedure Manual. Staff devised a tool for tracking complications and a checklist to assure competency of the nurses and technologists responsible for sheath removal. Our definition of bleeding as a complication is the same as that in the bivalirudin trials: bleeding that requires surgical intervention, transfusion, decline of > 3 gm/dl of hemoglobin, or prolongs hospitalization.⁷ 3) Educate staff. Cath lab staff provided inservices to the CCU nurses, PCI unit nurses, and cardiac med-surg nurses to familiarize them with the FemoStop device. CCU nurses spent a day in the cath lab pulling sheaths after diagnostic procedures to familiarize themselves with the procedure and increase their comfort level. Cath lab staff observed and provided feedback to CCU nurses when removing sheaths after interventional procedures in the CCU. Radi Medical Systems provides feedback in the form of continuing inservices and demonstrations in using the device. 4) Evaluate the plan. We evaluate the bleeding complication rate at our monthly QI meetings. The cath lab director provides feedback to the physicians performing the procedure and QI staff addresses the nurse pulling the sheaths, if known. Constant, constructive feedback is essential in any QI plan to assure optimal results. 5) Redefine the plan. Based on our results, the plan needs very little redefining at this time. Initially, we reformulated our data collection tool to reflect our findings. Regular in-services maintain the staff’s skill level. Vascular Outcomes Following the Implementation of QI Plan For calendar year 2003, a detailed analysis of prospectively collected QI data focusing on vascular complications was undertaken. The definition of severe bleeding was based on the REPLACE-2 criteria, but any transfusion or any drop in hemoglobin > 3gm/dL was considered to be an endpoint. Nine hundred patients underwent PCI, and follow-up was available on 893 patients. This is a 99% follow-up rate by the QI nurse. Of these, 67% were male. Mean age was 65 years. A smoking history was present in 61%, 25% were diabetic, 73% had hyperlipidemia, and 74% had hypertension. Acute MI was the indication for PCI in 98 patients (10.8%). Primary PCI was performed in 51 patients (5.6%) and rescue PCI in 47 patients (5.2%). Use of GP IIb/IIIa inhibitors occurred in 63% of patients. Only 21 (2.4%) patients had documentation for severe bleeding. There were no deaths due to bleeding events. This event rate compared favorably with the bivalirudin arm of the REPLACE-2 trial (2.4%) and was lower than the heparin arm of that trial (4.1%, p = 0.02). Of note, when data are analyzed using slightly more strict criteria than those in REPLACE-2, the incidence of a major bleeding event in an unselected PCI population that received UFH and selected GP IIb/IIIa inhibitor use was the same as the bivalirudin arm of REPLACE-2. This suggests that the technique used for sheath removal may be as important as the choice of anticoagulant. Benefits of FemoStop Device When considering hemostasis for invasive procedures, the comfort of staff and patients is paramount. Staff becomes susceptible to repetitive stress injuries (RSI), which have multiple causes.⁸ The definition of repetitive motions is making the same movements multiple times a day on a daily basis. RSI develop over a period of weeks, months or years.⁹ Awkward movements associated with sheath removal including bending, twisting or overextension of extremities. Standing for long periods and pressing against the force of blood flow causes RSI. Use of the FemoStop device prevents RSI by maintaining hands-free compression using a precise, controlled method. Personnel are able to visualize the puncture site, and after the initial occlusion of the artery for hemostasis, allow distal flow to the extremity. Steady, even pressure applied versus manual pressure improves both staff and patient comfort. Minimizing the exposure to blood is another benefit of the FemoStop device (www.radi.se/education). Points to Emphasize 1. Good groin management coupled with a rigorous QI program is essential and minimizes complications. Timely follow-up after procedures and documentation of any complications and their treatment allow for precise data collection and evaluation. 2. Competent groin management is as important as the anti-thrombotic regimen in minimizing complications. Sheath removal performed by qualified staff, comfortable with routine and complicated procedures reduces complications. We use the FemoStop proactively in the prevention of groin complications such as hematomas, A-V fistulas and pseudoaneurysms. 3. Cost. The FemoStop device costs approximately $75. The cost of a complication in increased hospital stay, lab monitoring of H/H, thrombin injection in the case of pseudoaneurysm and/or transfusion in the setting of a precipitous drop in hemoglobin are prohibitively high. The use of alternate closure devices such as a suture-mediated device is over $200. Cost for employee injury due to RSI is also a major factor.⁸ 4. Patient comfort and improved efficiency over manual compression. A closure device is not always successful and has potential to increase vascular complications. Constant, even manual pressure is difficult to maintain for a long period, and is stressful for both patient and staff. The FemoStop allows hands-free management of the patient and optimal visualization of the sheath insertion site.¹⁰ 5. Safety. Patient safety focuses on a decreased major bleeding complication rate. Personnel safety focuses on minimizing risk associated with exposure to blood and RSI. The authors can be contacted at fern.kaufman@uphs.upenn.edu

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