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Vascular Complications after Percutaneous Coronary Intervention
Following Hemostasis with the Mynx Vascular Closure Device
Versus the AngioSeal Vascular Closure Device
Shah Azmoon, MD, Anthony L. Pucillo, MD, Wilbert S. Aronow, MD, Ramin Ebrahimi, MD*, Joseph Vozzolo, MD, Archana Rajdev, MD, Kumar Kalapatapu, MD, Jae H. Ro, MD, Craig Hjemdahl-Monsen, MD ABSTRACT: We investigated the prevalence of vascular compli-
90%.1–3 They have been indicated as a safe alternative to manual cations after PCI following hemostasis in 190 patients (67% men and compression with a procedure-related mortality of < 0.5%.4 33% women, mean age 64 years) treated with the AngioSeal vascular VCDs have been shown to carry significant advantages over the closure device (St. Jude Medical, Austin, Texas) versus 238 patients (67% current gold standard of manual compression for achieving men and 33% women, mean age 64 years) treated with the Mynx vas-
cular closure device (AccessClosure, Mountain View, California). Results.
homeostasis following percutaneous vascular procedures. In mul- Death, myocardial infarction or stroke occurred in none of the 190 tiple studies, VCDs have been shown to decrease the time to am- patients (0%) treated with the AngioSeal versus none of 238 patients bulation as well as hospital discharge with improved (0%) treated with the Mynx. Major vascular complications occurred post-procedure patient comfort when compared to manual com- in 4 of 190 patients (2.1%) treated with the AngioSeal versus 5 of 238 pression.1–3 However, the use of VCDs is not without risks.
patients (2.1%) treated with the Mynx (p not significant). Major vas- Complications of VCDs can include minor bleeding with cular complications in patients treated with the AngioSeal included re- hematoma formation as well as major bleeding such as retroperi- moval of a malfunctioning device (1.1%), hemorrhage requiringintervention (0.5%) and hemorrhage with a loss of > 3g Hgb (0.5%).
toneal hemorrhage, pseudoaneurysm formation, arteriovenous The major vascular complications in patients treated with the Mynx fistulas, thromboembolic events or device malfunction requiring included retroperitoneal bleeding requiring surgical intervention surgical intervention.5 With increased use of antithrombin and (0.8%), pseudoaneurysm with surgical repair (0.8%) and hemorrhage dual antiplatelet regimens in recent years, the most common with a loss of > 3g Hgb (0.4%). These complications were not signif- complications of bleeding have been noted to be as high as 9% icantly different between the two vascular closure devices (p = 0.77).
post PCI.3,5,8 Moreover, the risk of complications can also be de- Minor complications included hematoma > 5 cm (0.5%, n = 1) within pendent on the severity of an individual patient’s procedural the AngioSeal group, as well as procedure failure requiring > 30 min-utes of manual compression after device deployment, which occurred risks such as obesity, high arteriotomy site, procedure duration, in 7 out of 190 patients (3.7%) treated with the AngioSeal versus 22 and bleeding diathesis as well as the different closure mechanisms of 238 patients with the Mynx (9.2%) (p = 0.033). Conclusions.
which are inherent to each type of VCD.5,8,9 Major vascular complications after PCI following hemostasis with vas- Development of VCDs began in the mid-1990s and the An- cular closure devices occurred in 2.1% of 190 patients treated with the gioSeal VCD (AngioSeal, St. Jude Medical, St. Paul, Minnesota) AngioSeal vascular closure device versus 2.1% of 238 patients treated was one of the forerunner VCDs for percutaneous arteriotomy with the Mynx vascular closure device (p not significant). The Mynxvascular closure device appears to have a higher rate of device failure. closure. Despite numerous upgrades, the AngioSeal VCD hascontinued to be one of the most widely used VCDs using an anchor-arteriotomy-collagen sandwich to achieve femoral access Key words: vascular closure device, Mynx, AngioSeal, hemorrhage,
hemostasis supplemented by the coagulation-inducing proper- percutaneous coronary intervention, pseudoaneurysm ties of its collagen sponge.6,7 More recently, a new VCD (Mynx,AccessClosure, Mountain View, California) has been developed Vascular closure devices (VCDs) are commonly used in pa- which uses an extravascular polyethylene glycol sealant that ex- tients undergoing percutaneous coronary intervention (PCI). In pands several times its original size upon contact with blood most instances, success rates for femoral access hemostasis exceed and subcutaneous fluids to seal the arteriotomy, and is eventu-ally hydrolyzed. Limited data exist on the safety and efficacy of From New York Medical College, Department of Cardiology, Macy Pavilion, Val- the Mynx VCD in comparison to more commonly used VCDs.
halla, New York and *UCLA, Department of Cardiology, Los Angeles, California.
We sought to evaluate vascular complications after PCI with The authors report no conflicts of interest regarding the content herein. This the Mynx VCD versus one of the more common VCDs used study was funded internally by NYMC without any outside grant, contracts, orfinancial support. A scientific session travel stipend for abstract presentation at our institution, the AngioSeal VCD.
Manuscript submitted November 20, 2009, provisional acceptance given December 2, 2009, final version accepted January 18, 2010.
Address for correspondence: Shah Azmoon, MD, New York Medical Col- From January, 2008 to September, 2008, patients who pre- lege, Department Cardiology, Macy Pavilion, 95 Grasslands Road, Valhalla, NY,10595. E-mail: [email protected] sented to our institution for diagnostic left-heart catheterization Table 1. Baseline characteristics of patients with the AngioSeal
The primary endpoint was to evaluate the combined post-VCD major vascular complication rates between the Mynx VCD andthe AngioSeal VCD during the index hospitalization. VCD com- Variable
AngioSeal
p-Value
plications included retroperitoneal bleeding, a drop in hematocrit requiring blood transfusion, hemorrhage requiring surgical inter- vention, 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 in- jection or additional compression and AV fistula not requiring sur- gical 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 deploy- ment of the sealant/collagen plug with > 30 minutes of manual Descriptive statistics (means and SD of continuous factors, NS = non significant; BMI = body mass index frequency counts and relative frequencies of categorical factors)were computed by closure type (manual, Mynx or AngioSeal) (LHC) and underwent subsequent immediate PCI (including and overall. For comparisons between the Mynx and AngioSeal patients with acute coronary syndromes as well as those under- groups and other categorical or limited ordinal groups, the going elective PCI) were consecutively evaluated in a retrospec- Fisher’s exact test, as well as the Pearson’s chi-square test, with tive manner for concomitant immediate post-PCI use of the and without Yates corrections, were evaluated (corrected for Mynx VCD or AngioSeal VCD. Two hundred and thirty-eight continuity in 2 x 2 tables). Analyses of the relationships between patients in the Mynx group and 190 patients in the AngioSeal the Mynx and AngioSeal characteristics by various groups were group met our inclusion and exclusion criteria within these 9 performed using multilevel cross-tabulation tables to achieve months and were included in this study. All patients underwent chi-square values. For all analyses, the criterion for statistical LHC and PCI within the same time period via the same op- significance was set at p ≤ 0.05, two-tailed.
erator using standard techniques and using a 6 French (Fr)arterial sheath size. Anticoagulation after sheath insertion was accomplished using intravenous unfractionated heparin to We investigated the prevalence of vascular complications achieve a target activated clotting time (ACT) of 200–300 after PCI following hemostasis in 190 patients (67% men and seconds. All patients were pretreated with 325 mg of aspirin 33% women, mean age 64 years ± 11 years) treated with the daily and loaded with 600 mg of clopidogrel (300 mg if pre- AngioSeal VCD versus 238 patients (67% men and 33% viously on a daily 75 mg dose of clopidogrel for > 7 days). In women, mean age 64 years ± 11 years) treated with the Mynx patients in whom arterial closure was contemplated, a femoral VCD. Review of the baseline characteristics revealed no signif- arteriogram was performed prior to VCD insertion, and place- icant differences between the two groups (Table 1). ment of either closure device was performed according to stan- Death, myocardial infarction or stroke occurred in none of the dard techniques. Femoral angiographic characteristics of VCD 190 patients (0%) treated with the AngioSeal VCD versus none exclusion for all study patients included: 1) arteriotomy site of the 238 patients (0%) treated with the Mynx VCD (p not sig- above the inferior epigastric artery, 2) arteriotomy at or below nificant). Major vascular complications occurred in 4 of 190 pa- the common femoral bifurcation, 3) common femoral artery tients (2.1%) treated with the AngioSeal VCD versus 5 of 238 of < 5 mm in diameter, and/or 4) extensive common femoral patients (2.1%) treated with the Mynx VCD (p not significant).
artery calcification or significant plaque formation. Despite a Major vascular complications in patients treated with the long track record of AngioSeal VCD use at our institution, the AngioSeal VCD included mechanical device failure requir- type of arteriotomy closure was left to the discretion of the in- ing surgical removal of the malfunctioning device (1.1%, n terventionist, with a general predilection for Mynx VCD use = 2), hemorrhage requiring surgical intervention (0.5%, n when patients were likely to need repeat access or surgical inter- = 1) and hemorrhage with loss of > 3 g of hemoglobin re- vention within 1 month of VCD, mild peripheral vascular dis- quiring blood transfusion (0.5%, n = 1).
ease, but precluding AngioSeal VCD use, as well as when patients Major vascular complications in patients treated with the revealed a significant concern for any discomfort. Hemostasis in Mynx VCD included retroperitoneal bleeding requiring surgi- the laboratory was achieved by the VCD followed by 2–5 min- cal intervention (0.8%, n = 2), pseudoaneurysm requiring sur- utes of manual pressure in all patients. Time to ambulation gical repair (0.8%, n = 2) and hemorrhage with loss of > 3 g of was 2 hours post-VCD placement and 4 hours after manual hemoglobin requiring blood transfusion (0.4%, n = 1). These complications were not significantly different between the two Vascular Closure: Mynx Versus AngioSeal Table 2. Major and minor complications in patients with the AngioSeal
and fellows including the Perclose VCD (Abbott Vascular, Redwood City, California), the Starclose VCD (Abbott Vascu-lar), the AngioSeal VCD, and more recently, the Mynx VCD.
Complication
AngioSeal
p-Value
The AngioSeal VCD has been considered to be one of the easier VCDs to master at our institution, with a fairlylong track record. Its disadvantage, like other VCDs, is that its use is limited to access sites of 8 Fr or smaller. The col- lagen anchor of the AngioSeal has been labeled as non- thrombogenic; however, it has been reported to be a nidus for thrombus formation. Furthermore, the interior anchor also limits its utilization in the presence of severe peripheral vascular disease or when the arteriotomy incision is at or below the common femoral artery bifurcation.
The Perclose VCD uses an automated suture system for complete tissue apposition and has the potential advantages of leaving only a small amount of stitch within the vessel.
Repeat access can be immediate, and it is the only VCD that can accommodate closure of arteriotomy incisions greater than an 8 Fr size sheath. However, with device mal-function, it can result in the need for surgical intervention.
vascular closure devices (p = 0.77). Minor vascular complica- The Starclose VCD uses a nitinol clip and has the advantage tions included hematoma > 5 cm (0.5%, n = 1 vs. 0% n = 0; p of being extravascular. The Starclose VCD also has the dis- = NS) within the AngioSeal and Mynx cohorts, respectively.
advantage of its use being limited to the use of 8 Fr sheaths Procedure failure, defined as successful deployment of the sealant/collagen plug with more than 30 minutes of manual Other devices have been developed that have their own in- compression to obtain hemostasis occurred in 7 out of 190 pa- herent limitations. However, unlike the more commonly used tients (3.7%) treated with the AngioSeal VCD (average intra- AngioSeal VCD at our institution, the Mynx sealant is unique operative heparin dose 3,833 units) versus 22 of 238 patients in that its polyethylene glycol polymer is delivered to the ex- (9.2%) treated with the Mynx VCD (average intra-operative travascular surface and is said to be bio-inert and to reabsorb heparin dose 6,531 units); p = 0.033 (Table 2).
within < 30 days without scar formation, which can make re-gaining access at the same site less cumbersome for the oper- Discussion
ators and less painful for patients. As an example, the VCDs introduce a novel means for improving patient AngioSeal VCD requires re-sticks to be attempted 1 cm above comfort and accelerating ambulation after invasive cardio- its anchor and 30 days after its original placement. However, vascular procedures performed via femoral arterial access.
an original “high stick” can make a re-stick in such a case The Mynx VCD is noted to decrease time to hemostasis high-risk, and thus more likely lead to the avoidance of An- and ambulation in comparison to manual compression and gioSeal VCD use in such a case. We also did not measure pa- no use of a VCD. In our study, major vascular complica- tient discomfort in this study, however, our operators tions after PCI following hemostasis with a VCD occurred generally noted the least post-VCD inguinal discomfort with in 2.1% of 190 patients treated with the AngioSeal VCD the Mynx VCD. Furthermore, while we did not experience versus 2.1% of 238 patients treated with the Mynx VCD (p any VCD-related infectious complications in our study co- not significant). The Mynx VCD did have higher rates of horts, there does exist a small but important risk of VCD-re- procedural failure in maintaining hemostasis. However, it was lated infection.5 The Mynx product is also fairly new, and due noted that the Mynx cohort also carried higher risks for to its extravascular placement since the termination of this bleeding. In a subanalysis of procedural failure patients, the study, it has been occasionally used at our institution in pa- Mynx patients had a higher body mass index (BMI 30 kg/m2 tients with mild peripheral vascular disease in which use of for the Mynx VCD vs. a BMI of 24 kg/m2 for the AngioSeal the AngioSeal VCD may have been felt to be limited. It has VCD; p = 0.11), as well as use of higher doses of intravenous also been used in the side wall (versus direct anterior) or below heparin (average heparin dose in the Mynx group 6,500 USP the common femoral artery bifurcation arterial puncture sites.
units vs. 3,833 USP units in the AngioSeal group; p = 0.21).
However, such potential uses of the Mynx VCD need to be Furthermore, our center was an early adopter of the Mynx further evaluated in larger randomized clinical trials.
VCD, and our data include7 the learning curve of initial use Study limitations. This study was a retrospective evalu-
ation of patients undergoing two the use of different types Since their inception in the 1990s, there have been several of VCDs. Patients needing acute coronary intervention as well VCDs used at our institution by our interventional cardiologist as elective PCI were enrolled together. However, the milieu of acute coronary syndromes may present different rates of VCD References
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Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices the more routinely used AngioSeal VCD. Larger randomized compared with standard manual compression after cardiac catheterization: System- trials allowing broader physician experience with the Mynx are atic review and meta-analysis. JAMA 2004;291:350–357.
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