Vascular Complications after Percutaneous Coronary Intervention Following Hemostasis (see full title below)
- Volume 22 - Issue 4 - April, 2010
- Posted on: 3/31/10
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Vascular Complications after Percutaneous Coronary Intervention Following Hemostasis with the Mynx Vascular Closure Device Versus the AngioSeal Vascular Closure Device
ABSTRACT: We investigated the prevalence of vascular complications after PCI following hemostasis in 190 patients (67% men and 33% women, mean age 64 years) treated with the AngioSeal vascular closure device (St. Jude Medical, Austin, Texas) versus 238 patients (67% men and 33% women, mean age 64 years) treated with the Mynx vascular closure device (AccessClosure, Mountain View, California). Results. Death, myocardial infarction or stroke occurred in none of the 190 patients (0%) treated with the AngioSeal versus none of 238 patients (0%) treated with the Mynx. Major vascular complications occurred in 4 of 190 patients (2.1%) treated with the AngioSeal versus 5 of 238 patients (2.1%) treated with the Mynx (p not significant). Major vascular complications in patients treated with the AngioSeal included removal of a malfunctioning device (1.1%), hemorrhage requiring intervention (0.5%) and hemorrhage with a loss of > 3g Hgb (0.5%). The major vascular complications in patients treated with the Mynx included retroperitoneal bleeding requiring surgical intervention (0.8%), pseudoaneurysm with surgical repair (0.8%) and hemorrhage with a loss of > 3g Hgb (0.4%). These complications were not significantly different between the two vascular closure devices (p = 0.77). Minor complications included hematoma > 5 cm (0.5%, n = 1) within the AngioSeal group, as well as procedure failure requiring > 30 minutes of manual compression after device deployment, which occurred in 7 out of 190 patients (3.7%) treated with the AngioSeal versus 22 of 238 patients with the Mynx (9.2%) (p = 0.033). Conclusions. Major vascular complications after PCI following hemostasis with vascular closure devices occurred in 2.1% of 190 patients treated with the AngioSeal vascular closure device versus 2.1% of 238 patients treated with the Mynx vascular closure device (p not significant). The Mynx vascular closure device appears to have a higher rate of device failure.
J INVASIVE CARDIOL 2010;22:175–178
Key words: vascular closure device, Mynx, AngioSeal, hemorrhage, percutaneous coronary intervention, pseudoaneurysm
Vascular closure devices (VCDs) are commonly used in patients undergoing percutaneous coronary intervention (PCI). In most instances, success rates for femoral access hemostasis exceed 90%.1–3 They have been indicated as a safe alternative to manual compression with a procedure-related mortality of < 0.5%.4 VCDs have been shown to carry significant advantages over the current gold standard of manual compression for achieving homeostasis following percutaneous vascular procedures. In multiple studies, VCDs have been shown to decrease the time to ambulation as well as hospital discharge with improved post-procedure patient comfort when compared to manual compression.1–3 However, the use of VCDs is not without risks. Complications of VCDs can include minor bleeding with hematoma formation as well as major bleeding such as retroperitoneal hemorrhage, pseudoaneurysm formation, arteriovenous fistulas, thromboembolic events or device malfunction requiring surgical intervention.5 With increased use of antithrombin and dual antiplatelet regimens in recent years, the most common complications of bleeding have been noted to be as high as 9% post PCI.3,5,8 Moreover, the risk of complications can also be dependent on the severity of an individual patient’s procedural risks such as obesity, high arteriotomy site, procedure duration, and bleeding diathesis as well as the different closure mechanisms which are inherent to each type of VCD.5,8,9
Development of VCDs began in the mid-1990s and the AngioSeal VCD (AngioSeal, St. Jude Medical, St. Paul, Minnesota) was one of the forerunner VCDs for percutaneous arteriotomy closure. Despite numerous upgrades, the AngioSeal VCD has continued to be one of the most widely used VCDs using an anchor-arteriotomy-collagen sandwich to achieve femoral access hemostasis supplemented by the coagulation-inducing properties of its collagen sponge.6,7 More recently, a new VCD (Mynx, AccessClosure, Mountain View, California) has been developed which uses an extravascular polyethylene glycol sealant that expands several times its original size upon contact with blood and subcutaneous fluids to seal the arteriotomy, and is eventually hydrolyzed. Limited data exist on the safety and efficacy of the Mynx VCD in comparison to more commonly used VCDs. We sought to evaluate vascular complications after PCI with the Mynx VCD versus one of the more common VCDs used at our institution, the AngioSeal VCD.
From January, 2008 to September, 2008, patients who presented to our institution for diagnostic left-heart catheterization (LHC) and underwent subsequent immediate PCI (including patients with acute coronary syndromes as well as those undergoing elective PCI) were consecutively evaluated in a retrospective manner for concomitant immediate post-PCI use of the Mynx VCD or AngioSeal VCD. Two hundred and thirty-eight patients in the Mynx group and 190 patients in the AngioSeal group met our inclusion and exclusion criteria within these 9 months and were included in this study. All patients underwent LHC and PCI within the same time period via the same operator using standard techniques and using a 6 French (Fr) arterial sheath size. Anticoagulation after sheath insertion was accomplished using intravenous unfractionated heparin to achieve a target activated clotting time (ACT) of 200–300 seconds. All patients were pretreated with 325 mg of aspirin daily and loaded with 600 mg of clopidogrel (300 mg if previously on a daily 75 mg dose of clopidogrel for > 7 days). In patients in whom arterial closure was contemplated, a femoral arteriogram was performed prior to VCD insertion, and placement of either closure device was performed according to standard techniques. Femoral angiographic characteristics of VCD exclusion for all study patients included: 1) arteriotomy site above the inferior epigastric artery, 2) arteriotomy at or below the common femoral bifurcation, 3) common femoral artery of < 5 mm in diameter, and/or 4) extensive common femoral artery calcification or significant plaque formation. Despite a long track record of AngioSeal VCD use at our institution, the type of arteriotomy closure was left to the discretion of the interventionist, with a general predilection for Mynx VCD use when patients were likely to need repeat access or surgical intervention within 1 month of VCD, mild peripheral vascular disease, but precluding AngioSeal VCD use, as well as when patients revealed a significant concern for any discomfort. Hemostasis in the laboratory was achieved by the VCD followed by 2–5 minutes of manual pressure in all patients. Time to ambulation was 2 hours post-VCD placement and 4 hours after manual compression alone.
The primary endpoint was to evaluate the combined post-VCD major vascular complication rates between the Mynx VCD and the AngioSeal VCD during the index hospitalization. VCD complications included retroperitoneal bleeding, a drop in hematocrit requiring blood transfusion, hemorrhage requiring surgical intervention, pseudoaneurysm formation necessitating surgical repair and the need for surgical removal of a malfunctioning VCD device. Secondary endpoints included minor vascular complication rates, device failure and procedure failure. Minor complications included hematoma > 5 cm, pseudoaneurysms treated with thrombin injection or additional compression and AV fistula not requiring surgical treatment. Device failure was defined as failure to deploy a sealant/collagen plug with conversion to manual compression or a C-clamp, and procedure failure was defined as successful deployment of the sealant/collagen plug with > 30 minutes of manual compression to obtain hemostasis.
Descriptive statistics (means and SD of continuous factors, frequency counts and relative frequencies of categorical factors) were computed by closure type (manual, Mynx or AngioSeal) and overall. For comparisons between the Mynx and AngioSeal groups and other categorical or limited ordinal groups, the Fisher’s exact test, as well as the Pearson’s chi-square test, with and without Yates corrections, were evaluated (corrected for continuity in 2 x 2 tables). Analyses of the relationships between the Mynx and AngioSeal characteristics by various groups were performed using multilevel cross-tabulation tables to achieve chi-square values. For all analyses, the criterion for statistical significance was set at p ≤ 0.05, two-tailed.
We investigated the prevalence of vascular complications after PCI following hemostasis in 190 patients (67% men and 33% women, mean age 64 years ± 11 years) treated with the AngioSeal VCD versus 238 patients (67% men and 33% women, mean age 64 years ± 11 years) treated with the Mynx VCD. Review of the baseline characteristics revealed no significant differences between the two groups (Table 1).
Death, myocardial infarction or stroke occurred in none of the 190 patients (0%) treated with the AngioSeal VCD versus none of the 238 patients (0%) treated with the Mynx VCD (p not significant). Major vascular complications occurred in 4 of 190 patients (2.1%) treated with the AngioSeal VCD versus 5 of 238 patients (2.1%) treated with the Mynx VCD (p not significant). Major vascular complications in patients treated with the AngioSeal VCD included mechanical device failure requiring surgical removal of the malfunctioning device (1.1%, n = 2), hemorrhage requiring surgical intervention (0.5%, n = 1) and hemorrhage with loss of > 3 g of hemoglobin requiring blood transfusion (0.5%, n = 1).
Major vascular complications in patients treated with the Mynx VCD included retroperitoneal bleeding requiring surgical intervention (0.8%, n = 2), pseudoaneurysm requiring surgical repair (0.8%, n = 2) and hemorrhage with loss of > 3 g of hemoglobin requiring blood transfusion (0.4%, n = 1). These complications were not significantly different between the two vascular closure devices (p = 0.77). Minor vascular complications included hematoma > 5 cm (0.5%, n = 1 vs. 0% n = 0; p = NS) within the AngioSeal and Mynx cohorts, respectively. Procedure failure, defined as successful deployment of the sealant/collagen plug with more than 30 minutes of manual compression to obtain hemostasis occurred in 7 out of 190 patients (3.7%) treated with the AngioSeal VCD (average intra-operative heparin dose 3,833 units) versus 22 of 238 patients (9.2%) treated with the Mynx VCD (average intra-operative heparin dose 6,531 units); p = 0.033 (Table 2).