Risk of Local Adverse Events following Cardiac Catheterization by Hemostasis Device Use — Phase II
- Volume 17 - Issue 12 - December, 2005
- Posted on: 8/1/08
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Reports to the Center for Devices and Radiological Health (CDRH) of the FDA regarding serious injuries and deaths associated with the use of vascular hemostasis devices1 provided the impetus for this study. These devices are used primarily to stop bleeding from the femoral artery catheterization site following cardiac diagnostic or interventional procedures. The most commonly used hemostasis devices provide two types of mechanisms for percutaneously controlling bleeding, either deploying sutures to close the femoral puncture site or re-absorbable collagen plugs to temporarily seal the arteriotomy, so as to allow the natural hemostatic process to take place.
Studies that have assessed the risks of vascular hemostasis device use compared to no device use (i.e., use of manual compression to stop bleeding) have produced mixed results with regard to the relative risks of serious adverse events (such as hemorrhage). Some have demonstrated no difference between device use versus manual compression controls,2–13 whereas others have shown a greater risk associated with device use14–18 or a lesser risk associated with device use.19–20 Despite the issuance of a public health notification by the FDA in 1999,21 reports of serious injuries and deaths associated with the use of these devices continued to occur without decrease in frequency. Consequently, the FDA conducted a study (Phase I), in collaboration with the American College of Cardiology (ACC), to assess the relative risk of serious complications following the use of the two main types of vascular hemostasis devices to stop bleeding from the femoral artery following diagnostic and therapeutic cardiac catheterization (as compared with manual compression), and to assess the relative rates of these complications by gender.22 That study, which included 2001 data from 214 institutions and 166,680 cardiac catheterizations, is by far the largest study to evaluate this issue. It showed that both types of hemostasis devices may provide some protection against these complications.
This study (Phase II) expands on the above study in the following ways:
1. It looks at some additional potential confounding variables that could provide an explanation for the apparent protective effects found in the first study. These additional variables include: activated clotting time (ACT) at the time of sheath removal; sheath size; current estrogen use; and history of previous interventional cardiac catheterization.
2. Individual assessment of the two different types of collagen plug devices (Angio-Seal™, St. Jude Medical, St. Paul, Minnesota, and VasoSeal®, Datascope Interventional Products, Mahwah, New Jersey).
3. Assessment of two additional devices, Chito-Seal™ (Abbott Vascular Devices, Redwood City, California) and the Syvek NT Patch® (Marine Polymer Technologies, Inc., Danvers, Massachusetts). These devices have been approved by the FDA as wound dressings, and not for vascular hemostasis. They are, however, sometimes used for hemostasis by physicians, generally in conjunction with some degree of manual or mechanical compression.
4. Assessment of local infection as one additional clinical outcome.
Source of data. The data used in this study were obtained from the American College of Cardiology-National Cardiovascular Data Registry™ (ACC-NCDR™).23 In 1998 the ACC-NCDR began recruiting U.S. facilities with cardiac catheterization laboratories to join their registry program. This registry collects 142 core data elements needed for measuring the clinical management and outcomes of patients undergoing diagnostic cardiac catheterizations and percutaneous coronary interventions. They have recruited institutions for this registry program via general marketing methods, including mass mailings to all catheterization laboratory programs in the U.S., scientific session exhibitions and ACC member referral. Although it is voluntary, several states are beginning to require ACC data collection to fulfill state reporting requirements. As of June 2004, 498 institutions had joined the program.
For this study, 59 sites were recruited to collect data from patients discharged between October 1 and December 31 of 2003. In conjunction with the normal data submission process, NCDR participants collected and submitted additional data designed specifically for this research project.
Data quality. ACC-NCDR™ participants submit data quarterly. Prior to analyzing data submitted for any given quarter, Registry staff established the overall completeness of a participant’s data submission and provided feedback via a Data Quality Report (DQR) to the participant. The DQR provides the participant with a confidential analysis of the data submission’s completeness and consistency, and is used by the participant to help prioritize data cleaning efforts and to assess the necessity for resubmission. Upon receipt of the DQR, participants are encouraged to resubmit at any time during the Call for Data period to improve the overall completeness of their data.
In order for a data submission to be included in the ACC-NCDR™, each data element must be 95–100% complete. In other words, no element may have more than 5% missing data or the submission will be excluded from the registry’s NCDR averages. Completeness thresholds were chosen for their clinical and structural pertinence.
Outcomes and definitions. Ten specific complications and one aggregate category related to the femoral artery catheterization site were assessed:
Bleeding: Blood loss at the site of arterial or venous access, or due to perforation of a traversed artery or vein requiring transfusion and/or prolonging the hospital stay, and/or causing a drop in hemoglobin > 3.0 gm/dl. Bleeding attributable to the vascular site could be retroperitoneal (retroperitoneal bleeding), a local hematoma > 10 cm. (hematoma bleeding), or external (entry site bleeding).
Occlusion: Total obstruction of the artery by thrombus, usually at the site of access requiring surgical repair. Occlusions may be accompanied by the absence of a palpable pulse or Doppler.
Loss of distal pulse: Loss of distal pulse requiring therapy.
Dissection: A disruption of an arterial wall resulting in splitting and separation of the intimal (subintimal) layers.
Pseudoaneurysm: The occurrence of a disruption and dilation of the arterial wall without identification of the arterial wall layers at the site of the catheter entry demonstrated by arteriography or ultrasound.
AV fistula: A connection between the access artery and the accompanying vein demonstrated by arteriography or ultrasound and most often characterized by a continuous bruit.
Infection: Infection occurring at the percutaneous entry site associated with a positive culture at the entry site and/or treatment with antibiotics.
Surgical device removal: Necessity to surgically remove the closure device from the artery.
Any vascular complication: Any of the above, other than infection
Inclusion/exclusion criteria. Catheterization laboratory discharges for the last quarter of the year 2003 were included in the analysis. Excluded from the analysis were: 1) Any subject for whom information was not complete with regard to gender, type of procedure or type of hemostasis; 2) Admissions were excluded from the univariate analysis if they lacked information on the applicable variables, and from the individual multivariate analyses if they lacked information on any of the variables used in the final regression equation.
Statistical analysis. We performed step-wise backwards multiple logistic regression using each of the outcome variables individually as the dependent variables, and using age, gender, race (white versus non-white), type of procedure (diagnostic versus interventional cardiac catheterization), type of hemostasis, body mass index (BMI), several indices of comorbidity (New York Heart Association classification, presence of diabetes, hypertension, peripheral vascular disease, left main coronary artery stenosis and shock, history of congestive heart failure, acute renal failure and previous recent interventional cardiac catheterization, emergency versus elective status of the procedure), sheath size and the number of cardiac catheterizations performed by the institution during the quarter (greater than or less than the average of 562).
This analysis was performed separately for each outcome characterized by 25 or more occurrences. It was also performed separately for each device, and manual compression, characterized by 300 or more uses. The devices included Perclose (Abbott Vascular Devices), Vasoseal, Angio-Seal, Chito-Seal, Syvek Patch and mechanical compression. Device use was defined according to the first method of hemostasis used in each subject, regardless of what subsequent methods were used. For each multivariate analysis that assessed a specific device, the independent variable that indicated device use included only subjects for whom that device or manual compression was used as the first method of hemostasis. Thus, these analyses assessed the role of each device separately, using manual compression as a control. In each analysis, if the final regression equation did not include gender or device use, these variables were then added.