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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, Augusto D. Pichard, MD, FACC, Kenneth M. Kent, MD, PhD, FACC, 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
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

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

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