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The Official Journal of the International Andreas Gruentzig Society
Friday, May 16, 2008


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Peripheral Interventions

The percutaneous treatment of arterial and venous disease affecting all areas of the body, excluding the cerebrovascular, carotid and cardiovascular systems. Peripheral vascular disease especially affects the renal arteries, mesenteric arteries and leg arteries (claudication). Diagnosis of peripheral vascular disease can be made noninvasively, through simple ankle-brachial indexing or via computed tomography or magnetic resonance imaging. Invasive means of diagnosing peripheral vascular disease is done in the catheterization laboratory with angiography. Balloon angioplasty and stent placement are performed in the catheterization laboratory to treat peripheral vascular disease.

Use of Bivalirudin as the Foundation Anticoagulant during Percutaneous Peripheral Interventions
Objective. The objective of this retrospective chart review was to evaluate the safety and feasibility of using the direct thrombin inhibitor bivalirudin as the procedural anticoagulant in patients undergoing percutaneous peripheral intervention (PPI). Background. Patients with peripheral artery disease are in general a high-risk population that requires safe and reliable anticoagulation with complete thrombin inhibition. Bivalirudin, a direct thrombin inhibitor, has been shown to be as effective as heparin, but with fewer bleeding events in PCI trials, and recent data suggest that bivalirudin may provide the same benefits in PPI. Methods. This was a retrospective chart review of patients who underwent PPI with bivalirudin as the foundation anticoagulant. Bivalirudin was administered as a 0.75 mg/kg bolus, followed by a 1.75 mg/kg/hour infusion for the duration of the procedure. The primary endpoint was procedural success defined as residual stenosis less than or equal to 20%. Ischemic and hemorrhagic events were collected, as well as time-to-sheath removal, ambulation and discharge. Results. Data were collected for 150 patients. Procedural success was achieved in 98.5%. Ischemic events were low: death (2.0%), myocardial infarction (0.0%), urgent revascularization (0.8%). Major and minor hemorrhage occurred in 4.7% and 2.0% of patients, respectively. Time-to-sheath removal, ambulation and discharge were short. Conclusion. Bivalirudin provided effective anticoagulation in these generally high-risk patients undergoing PPI. Ischemic and bleeding events were low and comparable to those reported in the literature, suggesting that bivalirudin is safe to use in this population.



Expanded Applications of Rotational Atherectomy in Contemporary Coronary and Peripheral Interventional Practice
ercutaneous rotational atherectomy is mainly utilized in contemporary interventional practice to alter lesion compliance, facilitating stent delivery and antirestenotic drug delivery at the site of the underlying lesion. This enables a percutaneous revascularization strategy in a group of patients who would otherwise require a surgical revascularization. We identify and present three novel uses for this device in percutaneous coronary and peripheral interventional procedures, which further expands the applications of rotational atherectomy.



Combined Peripheral and Coronary Artery Percutaneous Intervention in Patients with Significant Coronary and Peripheral Vascular Disease. Case Reports and Review
Combined percutaneous coronary and peripheral intervention in patients with coronary and peripheral vascular disease can be time and cost saving. Despite the potential benefit, such hybrid procedures have been rarely reported. We report two cases of hybrid peripheral and coronary intervention that were performed at our institution with excellent outcomes. This is followed by a review of the literature.



Heparin in Peripheral Vascular Intervention ? Time for a Change?
Several important observations are made in this paper. An interesting finding in the analysis by Shammas et al. The potential for closure devices to decrease complications during peripheral intervention deserves further exploration.



A Safety and Feasibility Report of Combined Direct Thrombin and GP IIb/IIIa Inhibition with Bivalirudin and Tirofiban in Peripheral Vascular Disease Intervention: ?Treating Critical Limb Ischemia Like Acute Coronary Syndrome?
Background. The combination of glycoprotein (GP) IIb/IIIa inhibition and direct thrombin inhibition (DTI) with bivalirudin (Angiomax,? The Medicines Co., Cambridge, Massachusetts) have shown ischemic and hemorrhagic outcomes benefit in coronary interventions and may have similar benefits in percutaneous peripheral interventions (PPI). The high incidence of diabetes, chronic renal disease, platelet dysfunction, hypercoagulability, inflammation and a thrombus-rich environment make a GP IIb/IIIa and DTI combination with tirofiban (Aggrastat,® Merck & Co., Inc., Whitehouse Station, New Jersey) an attractive anticoagulation strategy in the PPI treatment of critical limb ischemia (CLI). Methods. Between May 1, 2001 and January 31, 2003, a CLI treatment group of 149 patients received PPI with bivalirudin (0.75 mg/kg bolus with 1.75 mg/kg/hour periprocedural infusion) and tirofiban (10 mcg/kg/minute bolus with 12-hour 0.1 mcg/kg/minute infusion) as an anticoagulation and antiplatelet strategy, and were compared to a matched unfractionated heparin (UFH) control group without GP IIb/IIIa inhibitors. Clinical and hemostasis outcomes were analyzed, including distal embolization (DE). Results. Procedural success was 95.9% and 97.3% in the UFH control group and DTI-GP IIb/IIIa group, respectively. Significant differences were observed in the sheath removal time < 2 hours (60.5% UFH group versus 19.4% DTI-GP IIb/IIIa group; p = < 0.0001). Vascular closure devices were used equally in both groups. No statistical significance was observed in major and minor complications, femoral access complications, acute (< 48 hours) or subacute (30 days) vessel thrombosis, and 6-month duplex ultrasound restenosis rate between the DTI-GP IIb/IIIa versus the UFH group. A trend towards statistical significance was observed in the 6-month secondary re-intervention and limb salvage rates (10.7% versus 18.8%, p = 0.0501 and 93.9% versus 88.5%, p = 0.053) in the DTI-GP IIb/IIIa versus the UFH group, respectively. Angiographical



The Angiomax Peripheral Procedure Registry of Vascular Events Trial (APPROVE): In-Hospital and 30-Day Results
Background ? High-risk patient characteristics and complexity of percutaneous peripheral intervention (PPI) procedures suggest a need for predictable and reliable anticoagulation. We undertook this study to assess the safety and efficacy of bivalirudin as the procedural anticoagulant in patients undergoing PPI of the renal, iliac, or femoral artery. Methods ? This was a prospective, open-label, single arm study in patients undergoing PPI of the renal, iliac, or femoral vessels to assess bivalirudin as the sole procedural anticoagulant (0.75 mg/kg bolus/1.75 mg/kg/hr infusion). The primary endpoint was procedural success defined as residual stenosis <= 20%. Secondary endpoints included ischemic events (death, myocardial infarction, unplanned revascularization, and amputation), and bleeding complications, as well as ACT values and times to sheath removal, ambulation, and discharge. Results ? 505 patients were enrolled at 26 sites. Procedural success was achieved in 95.0% of patients. Ischemic events were low (1.4%) and similar between vessel types. Protocol-defined major hemorrhage and TIMI major hemorrhage rates were 2.2% and 0.4%, respectively. Mean ACTs were similar among treatment groups (renal 353.8 seconds(s); iliac 335.9s, femoral, 343.5s). Conclusion ? Bivalirudin provided consistent anticoagulation and similar outcomes in all vessel types treated at the dose tested. Ischemic and bleeding event rates were low, demonstrating the safe use of bivalirudin as a procedural anticoagulant in PPI.



Use of Lepirudin During Percutaneous Vascular Interventions in Patients with Heparin-Induced Thrombocytopenia
Heparin-induced thrombocytopenia (HIT) is a well-known complication of heparin exposure and presents a clinical dilemma for patients undergoing percutaneous intervention (PI). Heparin cannot be used for thrombin inhibition and direct thrombin inhibitors offer an attractive alternative to heparin. We report our experience with lepirudin, a recombinant hirudin, used for PI in HIT patients. Methods. Patients undergoing PI with known diagnosis of HIT were assigned to varying doses of lepirudin, often in combination with a platelet glycoprotein (GP) IIb/IIIa inhibitor. Predetermined endpoints of safety and efficacy were assessed prospectively. Results. Twenty-five patients underwent a total of 36 interventions. Angiographic success was obtained in 100% of patients and clinical success (freedom from death, myocardial infarction, stroke or target vessel revascularization) in 92% of patients. There was 1 procedure-related mortality resulting from a retroperitoneal bleed. Three patients had minor bleeding. Conclusion. Lepirudin is efficacious as a replacement for heparin in patients with HIT undergoing PI. Caution should be used when using a combination of lepirudin, GP IIb/IIIa inhibitors, clopidogrel and aspirin.



Bivalirudin as a Foundation Anticoagulant in Peripheral Vascular Disease: A Safe and Feasible Alternative for Renal and Iliac Interventions
Background. Many heparin (UFH) limitations are overcome by bivalirudin (Angiomax®). The pharmacokinetic profile of bivalirudin appears well suited for percutaneous peripheral intervention (PPI), yet few data exist regarding its safety and feasibility in this setting. Methods. One hundred and eighty renal and 75 iliac PPIs performed between May 2001 and June 2002 with bivalirudin as anticoagulation were compared to a historical UFH control. Variables evaluated included thrombotic events, intracranial bleeding, major surgical complications, sheath removal time, vascular access complication, time to ambulate and length of stay (LOS). Follow-up included 6-month renal and iliac duplex ultrasound and ankle-brachial index. Results. Procedural success was achieved in 100% of patients treated with bivalirudin, with no thrombotic events, intracranial bleeding or major surgical complications observed. Procedural success was achieved in 179/180 (99%) renal and 74/75 (98.6%) iliac patients treated with UFH. Significant differences were observed for sheath removal time < 60 minutes (84% versus 59%; p < 0.0001), time to ambulation < 6 hours (75.5% versus 58%; p < 0.0005) and LOS < 24 hours (85.5% versus 72%; p = 0.002) in bivalirudin-treated renal PPI patients versus UFH-treated patients, respectively. Significant differences were also observed in favor of bivalirudin for the iliac PPIs for sheath removal time < 60 minutes (p = 0.012) and time to ambulation < 6 hours (p = 0.039). Following 6-month renal and iliac duplex ultrasound, repeat PPI was required in 7/180 (3.9%) and 9/180 (5%) of renal, and 3/75 (4%) and 4/75 (5.3%) of iliac patients treated with bivalirudin or UFH, respectively. Conclusion. Bivalirudin is a safe and feasible alternative anticoagulant in renal and iliac PPI and may offer decreased sheath removal time, time to ambulation and LOS. A larger prospective randomized multicenter trial is warranted.



Management of Iliac Stent Movement Complicating Peripheral Vascular Intervention: A Rescue Technique When Stent Deployment Malfunctions
Percutaneous transluminal peripheral angioplasty (PTA), with and without stenting, has become an effective, accepted, and safe approach for treating intermittent claudication and critical leg ischemia in selected patients. Percutaneous peripheral interventions are subject to complications that require unique solutions when compared to coronary interventions. We report a case of common iliac artery stenting complicated by stent migration and describe an approach to the management of this problem.



COMMENTARY: Fluoroscopy Times and Adverse Events: A Potentially Deadly Combination




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