The Duett Pro Sealing Device

A novel approach to vascular sealing.

By Robert Bersin, MD
 

IThe use of vascular sealing devices has increased in the last several years as clinicians attempt to improve patient comfort and minimize the duration of bed rest after diagnostic and interventional coronary and peripheral vascular procedures. Currently available devices have limitations, however, including deployment failure in 2% to 12% of cases,1 requirement for considerable technical expertise, prolonged learning curve, retained components restricting future groin access, delayed oozing of blood—even with successful device placement, and a possible increased incidence rate of delayed groin infection.

THE DEVICE
The Duett Pro sealing device (Vascular Solutions Inc., Minneapolis, MN) is a two-component system—a low-profile balloon catheter combined with a flowable procoagulant mixture containing bovine microfibrillar collagen and thrombin. Collagen is a potent platelet-activating substrate. Thrombin promotes effective hemostasis by converting fibrinogen to fibrin and accelerating the coagulation cascade. It is also a powerful platelet-activating agent acting synergistically with collagen.2

The balloon catheter is deployed through the existing introducer sheath to create a temporary seal of the arteriotomy. The procoagulant is delivered to the exterior surface of the artery through the sidearm of the introducer sheath. The procoagulant stimulates platelet- and thrombin-based clotting mechanisms to form a rapid, complete seal of both the arteriotomy and tissue tract (Figure 1).

The Duett was first evaluated in the pivotal randomized, controlled Simple and Effective Arterial Closure (SEAL) investigation involving 630 patients, and second in a nonrandomized, multicenter Continued Access Registry (CAR) involving 666 patients. The randomized investigation compared the performance of Duett (N = 392) to that of standard compression (N = 238). Clinical endpoints studied were time to hemostasis, time to ambulation, and incidence of major complications. Major complications included the need for vascular repair, bleeding requiring transfusion, infection requiring extended hospitalization, and antibiotic administration. In both diagnostic and interventional patients, use of the Duett resulted in statistically significant decreases in time to hemostasis and time to ambulation as compared with standard compression. There was no significant difference in the major complication rate overall between the Duett group and the standard compression group.

The CAR was designed to further evaluate the safety and efficacy of the Duett. Clinical endpoints were identical to those studied in the SEAL trial. Endpoint results for time to hemostasis and time to ambulation were consistent with those demonstrated in the randomized investigation. The incidence of major complications was 0.5%.

A separate analysis of safety and effectiveness was performed for the cohort of interventional patients receiving platelet GP IIb/IIIa receptor inhibitors at the time of Duett deployment. Interventional patients from both the SEAL and the CAR were pooled (N = 198). Endpoint results were compared to the cohort of interventional patients who were not receiving platelet GP IIb/IIIa receptor inhibitors at the time of deployment. Times to hemostasis and ambulation were equivalent with or without the use of platelet GP IIb/IIIa receptor inhibitors in Duett-treated patients. Incidence of major complications was similar for the two groups. The major complication rate for Duett with GP IIb/IIIa use was 2.5% compared to Duett with no GP IIb/IIIa use at 1.8%.

POTENTIAL ADVANTAGES
The Duett uses a liquid procoagulant and leaves no rigid anchors, plugs, or sutures behind to interfere with reaccess or promote infection. No infections were reported in the 666 patients in the CAR. Duett is also the only sealing device to seal both the arteriotomy and the tissue tract with a flowable procoagulant. Duett’s complete seal minimizes the likelihood of oozing, inflammation, and other puncture site complications and enhances patient comfort (Figures 2 and 3).

Hospital costs also may be reduced by use of the Duett. The Study of Economic and Quality of Life (SEQOL), a substudy of the SEAL trial, evaluated the impact of the Duett on hospital costs, functional status, and quality of life.3 Charges associated with the procedural hospitalization were obtained from the UB92 formulation of the hospital bill. UB92s were obtained for 358 patients in the study. Charges from each hospital were converted to costs using the Medicare cost/charge ratios. A separate analysis of the SEQOL study was carried out for observation and recovery room costs. One hundred forty-three of the 358 UB92s obtained had recovery or observation room charges separately accounted for according to these revenue codes.

Use of the Duett demonstrated catheterization laboratory efficiencies and savings in hospitalization costs in diagnostic patients. The use of the Duett also resulted in $212 savings in total hospitalization costs per diagnostic case, inclusive of device cost and a 30% reduction in recovery room costs. Total hospitalization costs were also evaluated in interventional procedures, in which the Duett resulted in no increase in total hospitalization costs, inclusive of the device cost.

The Duett sealing device addresses several issues relative to other vascular sealing devices—no intra-arterial foreign body remains and rapid and complete hemostasis is achieved without tissue-tract oozing. The Duett has been highly effective in patients with high levels of anticoagulation, including the use of GP IIb/IIIa receptor inhibitors.

Robert Bersin, MD, is Director of Peripheral Invasive Laboratories, Carolinas Heart Institute, Charlotte, North Carolina, and Co-Director, Vascular Division, The Sanger Clinic, Charlotte, North Carolina. Dr. Bersin is a medical advisory board member for Vascular Solutions, Inc. He may be reached at (800) 627-6223; rbersin@sanger-clinic.com.

1. Silber S. Vascular closure devices for immediate sheath removal after coronary interventions: luxury or necessity? In: Ellis SG, Holmes DR, eds. Strategic approaches in coronary intervention II. Baltimore: Lippincott Williams & Wilkins; 1999.
2. Abbott WM, Austen, WG. The effectiveness and mechanism of collagen-induced topical hemostsis. Surgery. 1975;78:723-729.
3. Zhang Z, Mahoney E, Gershony G, et al. Impact of the Duett sealing device on quality of life and hospitalization costs for coronary diagnostic and interventional procedures: results from the Study of Economic and Quality of Life substudy of the SEAL trial. Am Heart J. 2001;142:982-988.

 

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