Groin Complications Thirty Days Post Cath Lab Procedure Following Hemostasis: Results of Manual Pressure Versus An Arterial Cl

Objectives: To compare digital manual compression versus an arterial closure device (ACD) in the incidence of groin vascular complications thirty days post cath discharge and document whether closure devices impact hospital readmissions and physician office visits as a result of a groin complications post discharge of cardiac cath procedure. Background: Since providing high quality healthcare is becoming more challenging in this era of decreasing reimbursement and increasing costs of technology, we compared 2 methods of hemostasis management to determine which was associated with the least negative outcomes after cath procedure discharge. Analysis of our inpatient (or in-hospital) groin complication rate from the manual compression method of hemostasis showed that it was quite low, at less than 1%. With a complication rate that low, there is little justification for utilizing arterial closure devices to decrease complications. However, there are a percentage of patients who present to the emergency room or physician office as a result of a groin complication after discharge. These patients may require readmission, surgical consultation and procedures, lab testing, or CT or ultrasound testing, all of which results in added costs to patient care. Some interventional cardiology professionals feel that closure devices may be able to prevent these incidences, thus significantly decreasing extra heath care costs to the patient and hospital. This study investigated the frequency of physician appointment and emergency room visits as a result of groin complications that occur with manual compression versus arterial closure device up to thirty days after a procedure discharge. Methods: A total of 391 patients (102 ACD and 289 manual pressure) were followed after discharge from a cath procedure using a transfemoral approach at the groin. Assessment was performed via telephone follow-up. Thirty days after the cath, patients were called and interviewed. Patients were interviewed and assessed for emergency room visits or unplanned physician appointments as a result of groin complications. The patient’s race, weight or gender were not considered or factored into the study. The following data was tracked: Type of cases performed; Sheath sizes and medications during the inpatient admission. Patients were also assessed for specific complications that occurred but did not result in a hospital or physician office visit. The ACD used in our study was the Angio-Seal (Minnetonka, MN). Numbers Breakdown: Of the 391 cases, 300 were diagnostic studies and 91 resulted in interventions (30%). Of the 300 diagnostic cases: 260 were left heart catheterizations; 22 were diagnostic peripheral cases; 18 were right and left heart catheterizations. Of the 91 interventions; 71 resulted in stent procedures 13 resulted in plain old balloon angioplasty (POBAs) 2 resulted in AngioJet® (Possis Medical Inc., Minneapolis, MN) cases, 3 were peripheral vascular interventions 2 resulted in Cutting Balloon (Boston Scientific Corporation, Maple Grove, MN) procedures. Sheath utilization breaks down as following: 228 of the cases were 6 Fr; 157 were 5 Fr; 4 were 7 Fr; 2 were 8 Fr. When examining medications, we observed that all 391 of the patients received an aspirin. A total of 117 (91 interventional and 26 diagnostic) patients received heparin before, during, or after the procedure. A total of 78 (71 interventional and 7 non-interventional) patients received Integrilin® (Millenium Pharmaceuticals Inc., Cambridge, MA) before, during or after the procedure. A total of 16 patients received Lovenox® (Aventis Pharmaceuticals, Bridgewater, NJ) in the Emergency Department before arrival to the cath lab. All 391 cases were reviewed. Of the 391: 91 were interventions and Angio-Seal was used on 21 of the interventions. 260 were diagnostic and Angio-Seal was used on 81 of these cases. Total use was 102 ACDs. Manual compression of the groin was used for the remainder of the cases. Results: The number of patients who were implanted with a closure device and who needed a physician office visit, emergency room visit, diagnostic testing (CT, ultrasound, etc), or diagnostic lab tests was zero. Five patients reported having smaller hematomas (Conclusions: We found no difference in unplanned physician office or emergency room visits up to 30 days following discharge from cath lab procedure when an arterial closure device was used versus manual digital compression. This also means that there is no decrease in post-discharge medical expenses related to groin complications when closure devices are used versus manual compression. In follow-up of 391 patients, 102 (26%) of whom received an ACD and 289 (73%) of whom received manual compression, we found that neither population required office or emergency room visits as a result of a groin complication after being discharged from the hospital after a cath from a transfemoral approach. Our overall post cath discharge groin complication rate is very low. In our Heart Center, only the cath lab and coronary care unit staff clinicians pull arterial sheaths. This is most likely the rationale for our low groin complication rate. We have a smaller population of staff who pull sheaths, thereby increasing their exposure to the process and thus resulting in a higher skill level. The benefit of closure devices would seem to be insignificant to our patient population. If manual compression is done effectively, patients have no greater chance of needing an office visit or emergency admission for a groin complication post discharge. Our average ambulation time for a diagnostic cath is between 4 and 6 hours. Our average ambulation time when a closure device is used is between 2 and 4 hours. Given that some patients do not ambulate for 4 hours even when a closure device is used almost eliminates any benefit of the product for our institution. We must further explore lowering our ambulation time when closure devices are used. In evaluating costs, we find that the average cost of one ACD is in the area $200 - $250 dollars. Costs associated with the manual compression technique are negligible. In a cost-benefit analysis, we find that the cost of the device does not warrant its routine use in our institution. Limitations: The primary limitation of this study was a low sample size. In order to more fully test our conclusions, a study with a more substantial population should be conducted to support or dispel our findings.

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