JOURNAL OF VASCULAR SURGERYVolume 51, Number 11S Abstracts 69S

incidence to be understated. In this ongoing study we com-pared the incidence of arrhythmias using two different moni-toring devices.

Methods: Patients with sinus rhythm were monitoredwith a 72-hour Holter electrocardiography device (Holter-ECG) (N � 350), and combined with a subcutaneouslyimplanted cardiac loop recorder (Reveal XT®) (N � 20),the latter starting one month prior to surgery, until it wasexplanted one month post-surgery. New-onset arrhythmiaswere noted. Thirty-day postoperative events, defined asMI, stroke, and cardiac death, were noted.

Results: New-onset perioperative arrhythmias were re-corded in 45 (13%) and 8 (40%) patients with Holter-ECGand Reveal respectively. In patients with perioperative ar-rhythmias, cardiovascular events occurred more frequently(OR 3.0, 95% CI 1.4-6.4). Using the Reveal device 4additional patients were identified who experienced periop-erative cardiovascular events. The incidence of cardiovascu-lar events with Holter and Reveal monitoring was 11/45(24%) and 4/8 (50%) respectively.

Conclusions: Vascular surgery patients may developparoxysmal arrhythmias outside the recording window ofthe 72-hour Holter ECG and are generally asymptomatic.Continuous implanted cardiac monitors can detect theseparoxysmal episodes of arrhythmias, which in turn couldhave important therapeutic consequences.

Author Disclosures: M. de Melis: Medtronic BCR Maas-tricht, Employment (full or part-time); W. Flu: Nothing todisclose; J. P. Oomen: Nothing to disclose; D. Polder-mans: Nothing to disclose; O. Schouten: Nothing todisclose; H. J. Verhagen: Nothing to disclose; M. T.Voute: Nothing to disclose; T. Winkel: Nothing to dis-close.

PS192.

Effectiveness of Vascular Sealant® Compared WithGELFOAM®/Thrombin for Control of AnastomosisSuture Line Bleeding: A Prospective, Randomized,Multi-center TrialSean O’Donnell, Ann Goetchues, Adriana Lins, CameronAkbari, Federick Beavers, Jacob Lustgarten, John Ricotta.Vascular and Endovascular Surgery, Washington HospitalCenter, Washington, DC.

Objectives: This study is a multi-center, prospective,randomized, controlled clinical trial that compared twomethods, the investigational Vascular Sealant and GEL-FOAM®/Thrombin, for treating anastomotic bleeding.The objective was to evaluate the safety and effectiveness ofthe Vascular Sealant compared with GELFOAM®/Thrombin when used to seal bleeding anastomotic suturelines.

Methods: Patients were randomized into the VascularSealant group or the Control GELFOAM®/Thrombingroup. The site (s) were assessed for bleeding immediately

and at intervals of 1, 3, 5, 7.5 and 10 minutes. Subjects

were assessed within 7 days of surgery and at 30 dayspost-procedure.

Results: A total of 69 subjects were randomized. Theoverall incidence of adverse events, including serious adverseevents, was comparable between the two study groups. Vas-cular Sealant group sealing success was achieved for 90.7% oftreated subjects [95% CI: 79.7%, 96.9%] and in the Controlgroup, success was 86.7% [95% CI: 59.5%, 98.3%] (p �0.072). The secondary endpoint of sealing success at theanastomosis level was established to be noninferior to theControl treatment (p � 0.048). Immediate Sealing Successwas significantly greater for the Vascular Sealant group com-pared with the Control group; 51.5% and 10.5%, respectively(p � 0.006).

Conclusions: Due to a small sample size the primaryendpoint did not reach significance. However secondaryendpoints did reach satistical significance and Vascular Seal-ant appears to be as safe and effective as GELFOAM®/Thrombin in stopping suture line bleeding. It has an ad-vantage in achieving immediate hemostasis in over half thecases. This product may be particularly suited for patientson antiplatelet and/or anticoagulant agents as well as thosewith known hemostatic deficiencies.

Author Disclosures: C. Akbari: Nothing to disclose; F.Beavers: Nothing to disclose; A. Goetchues: Nothing todisclose; A. Lins: Nothing to disclose; J. Lustgarten: Noth-ing to disclose; S. O’Donnell: Nothing to disclose; J.Ricotta: Nothing to disclose.

PS194.

Radiation Dose Optimization for Endovascular Aneu-rysm Repair (EVAR)Adrian O’Callaghan1, Colin L. Walsh2, GeraldineO’Reilly2, Jason Lee2, Mary P. Colgan1, Syed Haider1,Neil Cloete1, Sean M. O’Neill1, Prakash Madhavan1, Der-mot Moore1. 1Department of Vascular and EndovascularSurgery, St. James’s Hospital, Dublin, Ireland; 2Depart-ment of Medical Physics, St. James’s Hospital, Dublin,Ireland

Objectives: Endovascular aneurysm repair (EVAR) isan established treatment for aortic aneurysm (AAA). Al-though data is accumulating on radiation risk to patients,little attention is paid to the radiation doses in individualsteps of EVAR. We aimed to divide an EVAR procedureinto dose related steps to facilitate dose optimization.

Methods: Dose area product (DAP), digital acquisi-tion (DSA) and fluoroscopy times (FT) for 96 procedureswere analysed from our prospective EVAR database. Effec-tive dose was calculated using this and computed tomog-raphy (CT) dose data. Analysis of 7 procedures was used tobreak the EVAR into a series of component steps accordingto the radiation exposures. Phantom studies determinedthe typical entrance surface dose for each procedure step forthe range of exposure parameters selected for the EVARprocedures, including table height, position and field of

view (FOV).