Cath Lab Digest - February 2008 - (Page 46)

46 CLINICAL UPDATE FEBRUARY 2008 Incidence and Predictors of Vascular Complications after Invasive Coronary Procedures: A Prospective Analysis Neelima Penugonda, MD, Jennifer Jones, MD, J. Richard Spears, MD, Theodore Schreiber, MD Wayne State University, Detroit, Michigan Clinical characteristics and procedural data in 200 consecutive patients undergoing an invasive coronary procedure (CA = 124; PCI = 76) at a single large urban tertiary care center were collected prospectively during their hospital stay. Purpose The purpose of this study was to determine the incidence and potential predictors of hemorrhagic vascular complications after invasive coronary procedures, either diagnostic alone (contrast angiography [CA]) or combined with an interventional procedure (percutaneous coronary intervention [PCI]) in a tertiary care inner-city urban academic catheterization laboratory. Data Collection Methods and Procedure Clinical data of all patients who met the criteria were collected and entered into a database. The following agents were used pre-, peri- and post-procedure: aspirin, clopidogrel and heparin. Some patients got eptifibatide, bivalirudin or abciximab in addition to the above. Vascular access sheaths were used in every patient. The artery sheath sizes ranged from 5–8 French (Fr). A modified Seldinger technique was used to cannulate the common femoral artery before the bifurcation. Postprocedure, the artery was sealed either by femoral closure device, stasis patch and Femostop, or manual compression. All patients undergoing PCI received either 60 U/kg heparin bolus and a glycoprotein (GP) IIb/IIIa inhibitor or bilivarudin. The activated clotting time (ACT) was targeted to be between 250 and 300 seconds. The femoral sheaths were removed immediately after diagnostic procedures. The artery was sealed by a femoral closure device or manual compression. Usually, if the ACT is more than 250, a closure device is used and if it is less than 250, manual compression or a Femostop device is used. For PCI patients, the sheaths were removed immediately at the end of the procedure if a closure device was used or there was an evidence of expanding hematoma. The femoral sheaths were removed by trained personnel dedicated to the task on a vascular interventional unit or the coronary care unit when the ACT was < 160. The most commonly used closure devices were Angio-Seal (St. Jude Medical, Minnetonka, Minnesota) or Perclose (Abbott Laboratories, Redwood City, California). For mechanical hemostasis, the FemoStop® (Radi Medical Systems, Uppsala, Sweden) compression device was used. The sealer Abstract Background. Although clinical trial data suggest that the incidence of hemorrhagic vascular complications associated with invasive coronary procedures is relatively low, contemporary data from tertiary care centers are lacking. Objective. The purpose of the study was to determine the incidence and potential predictors of hemorrhagic vascular complications after invasive coronary procedures, either diagnostic alone (contrast angiography [CA]) or combined with an interventional procedure (percutaneous coronary intervention [PCI]). Methods. Clinical characteristics and procedural data in 200 consecutive patients undergoing an invasive coronary procedure (CA = 124; PCI = 76) at a single large urban tertiary care center were collected prospectively during their hospital stay. Multivariate logistic regression methods (SAS v9.1) were used to identify independent predictors of hemorrhagic vascular complications. Results. The overall incidence of hemorrhagic vascular complications was 10%. Subgroup analysis demonstrated a significant increase (p 75 min. (odds ratio = 4.9); and the use of eptifibitide (odds ratio = 7.0 compared to no eptifibitide), which was associated with a 40% incidence. Gender and BMI had no effect (p > .05). While the use of an arterial closure device was associated with a 45% lower complication rate, compared to without a device, this was not statistically significant (p > .05). Conclusions. The incidence of vascular complications in this large, singlecenter study is significant. Predictors of this complication include the use of eptifibitide, PCI, and procedure time > 75 min. Our data is unique, with reporting procedure time being one of the predictors. The above factors should be taken into consideration during invasive coronary procedures. Future similar studies with large patient population would add substantially to our current knowledge of vascular complications. Methods and Procedures Study design. The study design was a prospective observational study approved by the Institutional Review Board at our university. Patient selection. Clinical characteristics and information regarding procedural data were collected for 200 consecutive patients who underwent cardiac catheterization over a period of two months via femoral artery access. Inclusion criteria. The study included patients undergoing cardiac catheterization for diagnostic or percutaneous intervention. Exclusion criteria. Those patients who had an access site different from right or left femoral artery, documented coagulation disorders, anticoagulation on warfarin with international normalized ratio (INR) > 2.0 were excluded from the study. From the procedures using femoral access, there were 124 purely diagnostic and 76 percutaneous coronary interventions. A prospective cohort with femoral access site angiogram was collected and they were observed during the hospital stay. Complications. Hematoma was defined as a firm collection of blood greater than 2 cm around or in the proximity of the access site. Pseudoaneurysm/dissection, A-V fistula and ischemic leg were also considered, along with retroperitoneal bleed. Retroperitoneal bleeding was defined by any amount of bleeding in the retroperitoneum, diagnosed by computer tomography. Background Although clinical trial data suggest that the incidence of hemorrhagic and vascular complications associated with invasive coronary procedures is relatively low, contemporary data from “real world, nontrial related” data tertiary care centers are lacking. Access site complications are the most common cause of complications following cardiac catheterization procedures. The femoral approach is the most commonly used site of vascular access.1 Femoral access complication rates are 1.8% for diagnostic and 4% for interventional procedures.3 Even though a number of studies were done to look into such complications, the patients had to meet certain inclusion criteria in order to qualify for participation. Those studies tended to include patients with relatively few comorbidities and a good functional status. Our study includes all patients and, therefore, comes close to what is seen in everyday clinical practice. An increasing number of interventional procedures, along with intense anticoagulation, increase the need for identifying predictors of complications in order to minimize the risks. Reprinted with permission from Vascular Disease Management 2008;5(1):6–9.

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Cath Lab Digest - February 2008 Bay Regional Medical Center ENDEAVOR IV: A Zotarolimus-Eluting Stent Versus a Paclitaxel-Eluting Stent in a Randomized Clinical Trial A 3D CT Vessel “Roadmap” Over Live Fluoroscopy for Chronic Total Occlusions Contents Clinical Editor’s Corner An Evaluation of Cath Lab Turnaround Time Commentary: An Evaluation of Cath Lab Turnaround Time Excerpts from Chapter 19. STEMI Interventions – Future Perspectives The Potential Clinical Utility of Intravascular Ultrasound Guidance in Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents The Ten-Minute Interview with…Debbie Charlton, RN The Society of Invasive Cardiovascular Professionals (SICP) at Transcatheter Cardiovascular Therapeutics (TCT) 2007 The Cath Lab is a Business: Do You Have the Knowledge to Stay Afloat? Incidence and Predictors of Vascular Complications after Invasive Coronary Procedures: A Prospective Analysis Ask the Clinical Instructor: A Q&A Column for those New to the Cath Lab Volunteer Survey SICP* Section Meetings Calendar What Do You Think? CEU Education Center Clinical & Industry News Classifieds Advertisers Index

Cath Lab Digest - February 2008

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