- Email: [email protected]
Contained Pharmacomechanical Thrombolysis for DVT
9:20 a.m. Contained Pharmacomechanical Thrombolysis for DVT Kenneth D. Murphy, MD SUNY Health Science Center University Hospital Syracuse, NY
In December 2002 , the FDA announced clearance and commercial availability of a new and to date, unique catheter infuSion system for thro mbolytics. The Trellis ™ Reserve system (Bacchus Medical, Santa Cla ra, CA) was approved for treatment of acute limb ischemia and DVT. This system is a pe rcutaneous infusion catheter that can isolate and treat vascular thrombosis with standard thrombo lytic agents. The unique dual balloon design is crafted to ma intain the concentration of the infused fluid while it promotes mechanical dispersion of the fluid throughout the thrombosed segment. Additionally, this system allows for the aspiration of debris from the treated segment, which may potentially redu ce the risk of distal embolization. Thrombolytics continue to be the treatment of choice in managing patients with acute arterial limb ischemia, and demonstrate an evolving indication for management of patients with deep venous thrombosis (DVT). In this modern era of advanced technology and therapy, cost justification and containment predominate in medical decision-making. Several DVT management strategies continue to be investigated, with the goal of maximizing clinical outcome, minimizing complications and promoting the most significant cost savings. Pharmaco-economic studies have, and continue to be condu cted assessing such treatment strategies. Contained pharmaco-mechanica l thrombo lysis for DVT is an evolving technique of administering a thrombolytic agent via a contained infusion catheter system.
P74
apy (literature controls). Similarly, there was a decrease in Significant bleeding complication with this isolated infusion system when compared to catheter-directed thrombolytic therapy literature controls. In addition, they reported Significant cost benefit to the isolated infUSion system with respect to catheter-directed thrombolytiC thera py controls. 111is pre liminary analysis suggested that although there is a cost for the device, the overall impact on the patient's revascularization imparts a significant cost advantage 0). This inhlsion catheter system and the principles, therein , have been applied to DVT, and remains uninvestigational. The potential adva ntages of such a system may be to not only limit the dose and volume of a thrombolytiC agent, but potentially shorten the procedure length time and number of procedures to achieve venous lysis , reduce the bleeding complications, allow expansion of the thrombolytic therapy exclusion criteria, and minimize the risk of distal embo lization (PE). The effect of this device on underlying valves and vein intima remains under investigation. Further controlled studies evaluating the safety, efficacy, cost and long-term outcomes of such an isolated thrombolytic system combining pharmaco-mechanical techniques is warranted.
Reference 1. Sarac TP, Hilleman D, Arko F, Zarans C, Ouriel K. "Safety, Efficacy and Cost of a Single Combined Mechanical and Pharmacological Thrombectomy Catheter For Acute and Chronic Arterial Occlusion". SVS Annual Meeting, Chicago, 2003.
The Trellis reserve isolated thrombo lytic delivery cathe -
Coordinator/Moderator: Katharine L. Krol, MD
ter has initiated the interest in this concept with respect to managing patients with DVT. Briefly, the catheter system is a quad lumen, 6 Fr infusion catheter that has balloons situated at the proximal and distal margins of the infusion length. The balloons can be inflated to isolate the segment of thrombus vessel ta rgeted for thrombolytiC infusion. The thrombolytic agen t is introduced via a side hole in the infusion catheter. An oscillating nitinol wire is then inserted which situates within the infusio n zone between the balloons. The oscillating wire is activated by a motor drive unit at 1,500 rpm, to facilitate enhanced clot/ lytic agent exposure, as well as, potentially induce a mechanical effect. Upon completion of the activation, the isolated segment can be aspirated prior to balloon deflation. The safety, efficacy and cost of such a single-combined mechanical pharmacological isolated thrombectomy catheter has been reported in the alterial syste m. Sarac, et at reported 26 patients treated for lower extremity ischemia with contained pharmaco-mechanical thrombolysis (1). The technical success rate was 96%, compared to 81% for catheter-direct thrombolytiC ther-
Objectives: 1. Review what is known and how much is not known about women and PYD, including gender differences in the disease and treatments.
2. Identify potential marketing tools for IR practices. 3. Identify areas needing research regarding PYD in women, and identify 0ppoltunities for IR to do this research. 8:00 a.m.
PVD in Women: A Primary Care Physician's Perspective Susan Cole, MD Women's RefeJ7al Center, OSP Center for Healtb Peoria, IL 8:20 a.m.
Legs For Life® Data: Gender Differences and Trends Catberine M. Tuite, MD Hospital of the University of Pennsylvania Philadelphia, PA
In December 2002 , the FDA announced clearance and commercial availability of a new and to date, unique catheter infuSion system for thro mbolytics. The Trellis ™ Reserve system (Bacchus Medical, Santa Cla ra, CA) was approved for treatment of acute limb ischemia and DVT. This system is a pe rcutaneous infusion catheter that can isolate and treat vascular thrombosis with standard thrombo lytic agents. The unique dual balloon design is crafted to ma intain the concentration of the infused fluid while it promotes mechanical dispersion of the fluid throughout the thrombosed segment. Additionally, this system allows for the aspiration of debris from the treated segment, which may potentially redu ce the risk of distal embolization. Thrombolytics continue to be the treatment of choice in managing patients with acute arterial limb ischemia, and demonstrate an evolving indication for management of patients with deep venous thrombosis (DVT). In this modern era of advanced technology and therapy, cost justification and containment predominate in medical decision-making. Several DVT management strategies continue to be investigated, with the goal of maximizing clinical outcome, minimizing complications and promoting the most significant cost savings. Pharmaco-economic studies have, and continue to be condu cted assessing such treatment strategies. Contained pharmaco-mechanica l thrombo lysis for DVT is an evolving technique of administering a thrombolytic agent via a contained infusion catheter system.
P74
apy (literature controls). Similarly, there was a decrease in Significant bleeding complication with this isolated infusion system when compared to catheter-directed thrombolytic therapy literature controls. In addition, they reported Significant cost benefit to the isolated infUSion system with respect to catheter-directed thrombolytiC thera py controls. 111is pre liminary analysis suggested that although there is a cost for the device, the overall impact on the patient's revascularization imparts a significant cost advantage 0). This inhlsion catheter system and the principles, therein , have been applied to DVT, and remains uninvestigational. The potential adva ntages of such a system may be to not only limit the dose and volume of a thrombolytiC agent, but potentially shorten the procedure length time and number of procedures to achieve venous lysis , reduce the bleeding complications, allow expansion of the thrombolytic therapy exclusion criteria, and minimize the risk of distal embo lization (PE). The effect of this device on underlying valves and vein intima remains under investigation. Further controlled studies evaluating the safety, efficacy, cost and long-term outcomes of such an isolated thrombolytic system combining pharmaco-mechanical techniques is warranted.
Reference 1. Sarac TP, Hilleman D, Arko F, Zarans C, Ouriel K. "Safety, Efficacy and Cost of a Single Combined Mechanical and Pharmacological Thrombectomy Catheter For Acute and Chronic Arterial Occlusion". SVS Annual Meeting, Chicago, 2003.
The Trellis reserve isolated thrombo lytic delivery cathe -
Coordinator/Moderator: Katharine L. Krol, MD
ter has initiated the interest in this concept with respect to managing patients with DVT. Briefly, the catheter system is a quad lumen, 6 Fr infusion catheter that has balloons situated at the proximal and distal margins of the infusion length. The balloons can be inflated to isolate the segment of thrombus vessel ta rgeted for thrombolytiC infusion. The thrombolytic agen t is introduced via a side hole in the infusion catheter. An oscillating nitinol wire is then inserted which situates within the infusio n zone between the balloons. The oscillating wire is activated by a motor drive unit at 1,500 rpm, to facilitate enhanced clot/ lytic agent exposure, as well as, potentially induce a mechanical effect. Upon completion of the activation, the isolated segment can be aspirated prior to balloon deflation. The safety, efficacy and cost of such a single-combined mechanical pharmacological isolated thrombectomy catheter has been reported in the alterial syste m. Sarac, et at reported 26 patients treated for lower extremity ischemia with contained pharmaco-mechanical thrombolysis (1). The technical success rate was 96%, compared to 81% for catheter-direct thrombolytiC ther-
Objectives: 1. Review what is known and how much is not known about women and PYD, including gender differences in the disease and treatments.
2. Identify potential marketing tools for IR practices. 3. Identify areas needing research regarding PYD in women, and identify 0ppoltunities for IR to do this research. 8:00 a.m.
PVD in Women: A Primary Care Physician's Perspective Susan Cole, MD Women's RefeJ7al Center, OSP Center for Healtb Peoria, IL 8:20 a.m.
Legs For Life® Data: Gender Differences and Trends Catberine M. Tuite, MD Hospital of the University of Pennsylvania Philadelphia, PA