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J Am Coll Cardiol, 2001; 38:638-641
© 2001 by the American College of Cardiology Foundation
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CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY

Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices

George Dangas, MD, PhD, FACC*, Roxana Mehran, MD, FACC*, Spyros Kokolis, MD*, Dmitriy Feldman, MD*, Lowell F. Satler, MD, FACC{dagger}, Augusto D. Pichard, MD, FACC{dagger}, Kenneth M. Kent, MD, PhD, FACC{dagger}, Alexandra J. Lansky, MD*, Gregg W. Stone, MD, FACC* and Martin B. Leon, MD, FACC*

* Cardiovascular Research Foundation, Lenox Hill Heart & Vascular Institute, New York, New York, USA
{dagger} Washington Hospital Center, Washington, DC, USA

Manuscript received October 12, 2000; revised manuscript received April 19, 2001, accepted June 1, 2001.

Reprint requests and correspondence: Dr. Roxana Mehran, Lenox Hill Heart & Vascular Institute, Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10022


   Abstract
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 Abstract
Methods
 Results
 Discussion
 References
 
OBJECTIVES

We evaluated the vascular complications after hemostasis with arteriotomy closure devices (ACD) versus manual compression after percutaneous coronary interventions (PCI).

BACKGROUND

Previous clinical studies have indicated that ACD can be used for achievement of hemostasis and early ambulation after PCI. This study investigated the safety of ACD in achieving hemostasis after PCI compared with manual compression in a large cohort of consecutive patients.

METHODS

A total of 5,093 patients were followed after PCI was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with ACD (n = 516) or with manual compression (n = 5,892) as a hemostasis option after sheath removal.

RESULTS

The use of ACD was associated with a more frequent occurrence of hematoma compared with manual compression (9.3 vs. 5.1%, p < 0.001). There was also a higher rate of significant hematocrit drop (>15%) with ACD versus manual compression (5.2% vs. 2.5%, p < 0.001). Similar rates of pseudoaneurysm and arteriovenous fistulae were noted with either hemostasis technique. Vascular surgical repair at the access site was required more often with ACD versus manual compression (2.5 vs. 1.5%, p = 0.03).

CONCLUSIONS

In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

Abbreviations and Acronyms
  ACD = arteriotomy closure devices
  ACT = activated clotting time
  MACE = major adverse cardiac events
  MI = myocardial infarction
  PCI = percutaneous coronary interventions

After percutaneous coronary intervention (PCI), access site complications may necessitate surgical repair or blood transfusion (1–7). Sheath removal with manual compression can be performed few hours after completion of PCI and requires prolonged bed rest and delayed ambulation. Arteriotomy closure devices (ACD) may potentially allow earlier sheath removal and ambulation with a similar or decreased complication rate compared with manual compression. Although ACD have been tested in clinical studies before their approval for clinical use (8–17), no large report exists on their "real-world" application after approval.

This study reports on the safety of ACD use after PCI in comparison with hemostasis with manual compression in a large cohort of consecutive patients.


   Methods
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 Abstract
 Methods
Results
 Discussion
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We studied 5,098 patients who underwent 6,408 PCI procedures at the Washington Hospital Center from January 1996 through June 1999. We excluded patients with thrombolytic therapy, acute ST-elevation myocardial infarction (MI) or sheath size 10F or larger. All procedures were performed by experienced interventional cardiologists who performed both the arterial puncture and the ACD application in the catheterization laboratory. Sheath removal with manual compression was performed by dedicated technicians according to the Hospital protocol (activated clotting time [ACT] <150 s).

Hemostasis with manual compression was performed after 5,892 procedures (92%), whereas ACD were used in 516 procedures (8%) according to operator preference. Angioseal (Daig, St. Paul, Minnesota) was used in 371 procedures; Duett (Vascular Solutions, Minneapolis, Minnesota) was used in 32 procedures; Vasoseal (Datascope Corp., Montvale, New Jersey) was used in 6 procedures; Prostar was used in 6 procedures, and Techstar was used in 101 procedures (Perclose Inc., Redwood City, California). Femoral artery angiography was recommended before ACD application.

Hospital charts were reviewed to obtain the clinical, procedural and laboratory results. The occurrence of vascular complications and major adverse cardiac events (MACE) was recorded and adjudicated. All data were obtained from the computerized database of the Cardiovascular Research Foundation.

Statistics.   Continuous variables were expressed as mean ± SD and compared with unpaired Student t test. Categorical variables were compared with Fisher exact test. Multivariate logistic regression analysis was used to identify the independent predictors of in-hospital vascular complications controlling for baseline between-group differences. A two-tailed p value <0.05 was considered statistically significant.


   Results
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 Abstract
 Methods
 Results
Discussion
 References
 
Baseline patient characteristics are summarized in Table 1. Patients treated with manual compression had a smaller body size and a higher rate of previous MI and revascularization procedures than the ACD group.


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  		Table 1 Baseline Characteristics

 
Procedural variables are summarized in Table 2. The manual compression group was characterized by increased use of debulking devices, longer procedural duration, lower procedural ACT values and heparin doses. Platelet glycoprotein IIb/IIIa inhibitors were used infrequently in both groups.


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  		Table 2 Procedural Variables

 
In-hospital and vascular complications are shown in Tables 3 and 4,respectively. In-hospital mortality and MACE rates were similar between the two groups. Creatine kinase-MB enzyme elevations after PCI were more frequent in the ACD than in the manual compression group. Pseudoaneurysm and arteriovenous fistulae occurred infrequently in both groups.


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  		Table 3 In-Hospital Results

 

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  		Table 4 Vascular Complications

 
A significant drop of the hematocrit (>15%) occurred more often in the patients with ACD than in the patients with manual compression (5.2 vs. 2.5%, p < 0.001). Hematoma developed more often with ACD than it did with manual compression (9.3 vs. 5.1%, p < 0.001). Accordingly, a hematoma with a hematocrit drop >15% occurred 2.0 versus 0.6%, respectively (p < 0.001). Vascular surgery for access site repair was also performed more often in the ACD group compared with the manual compression group (2.5 vs. 1.3%, p < 0.03).

Rates of hematoma and surgical access site repair were: 10.4% and 2.4% with Angio-Seal; 6.3% and 3.1% with Duett; none (0 of 6) with Prostar; 7% and 2% with Techstar, and 17% (1 of 6) for both complications with Vasoseal. Due to the large sample size differences among the above subsets, no statistical comparisons were performed among them.

Independent predictors of vascular complications are shown in Table 5 (multivariate analysis). Any vascular complication was predicted by increased age, smaller body size and female gender. Hematoma with a hematocrit drop >15% was predicted by ACD use and smaller body size.


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  		Table 5 Predictors of Complications

 

   Discussion
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 Discussion
References
 
Vascular complications are common after cardiac catheterization and PCI with the transfemoral approach. The use of ACD may assist the operator in obtaining rapid hemostasis with early ambulation and ideally would achieve potentially fewer complications. Thus, the development of ACD may create improved patient comfort or allow earlier discharge from the hospital. Many types of ACD exist, and they use different materials and methods in achieving hemostasis. Each device has evolved into various designs allowing progressively easier delivery into the artery and more durable closure of the arteriotomy.

Arteriotomy closure devices have been found to achieve more rapid ambulation than manual compression with a comparable complication profile between the two groups in initial studies (13–19). However, no study has systematically compared the use of ACD with hemostasis by manual compression after PCI in a purely clinical setting, i.e. with ACD use in a large cohort after device approval was granted. In the present study, we found that ACD application was associated with increased vascular complications. Thus, the initial time to hemostasis that is gained with ACD may be counterbalanced with the slightly increased rate of certain vascular complications.

Several factors may be responsible for these results, and they need to be addressed carefully. First, operator training and experience with the ACD application is very important. In our study, operators were very experienced with arterial puncture; experience with ACD application was achieved on an individual basis. Instruction was offered from the manufacturers of the various ACD according to their guidelines. A femoral angiogram was used in the majority of cases, but there was no strict mandate for its performance. Second, device-related limitations might have also contributed to the above results. Early types of ACD were used in this study; the evolution of subsequent "generations" of ACD may have properly rectified initial imperfections of the "early" ACD types. Patient-related factors might also be important, as indicated by the predictors of vascular complications in the multivariate analysis of our study. Finally, the absence of a specific ACT value as a guideline for sheath removal in the ACD group might have also contributed to the greater complication rate versus manual compression (which was performed routinely when ACT <150 s).

Although detailed information has not been provided from any ACD study, it is possible that certain ACD may be superior than others for certain patient subsets according to clinical characteristics or femoral vascular anatomy. The major imbalances in the number of patients treated with each individual ACD prohibited any reliable comparison among them within this study, but it should certainly be carefully assessed in the future. For the very same reason, the findings of this study may not be applicable in all ACD types.

Further investigation should focus on each of these parameters and attempt to improve the technical characteristics, indications and operator-training for ACD use. In addition, careful regulatory process with continued surveillance after device approval and appropriate operator credentialing should be considered. Meanwhile, operators should apply ACD carefully, after they become considerably familiar with the specific device.

Study limitations.   This study was limited because of its retrospective, nonrandomized design. Specific types of ACD were also selected by the operator. There was no uniform, laboratory-initiated, standardized training for ACD selection and application. The "learning curve" phase of ACD needs to be taken into account when interpreting these results. No conclusions regarding differences among the various ACD should be drawn as a result of this study because certain subgroups had a very limited patient number. Finally, these results may not be applicable in the newer ACD "generations" or in the absence of a dedicated well-trained sheath removal with manual compression team.

Conclusions.   In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.


   References
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 Abstract
 Methods
 Results
 Discussion
 References
 

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