Defining the optimal degree of heparin anticoagulation for peripheral vascular interventions: insight from a large, regional, multicenter registry.

BACKGROUND: The optimal degree of heparin anticoagulation for peripheral vascular interventions (PVIs) has not been defined. We sought to correlate total heparin dose and peak procedural activated clotting time (ACT) with postprocedural outcomes in patients undergoing PVI. METHODS AND RESULTS: We studied 4743 patients who received heparin during PVIs in a regional, multicenter registry. From those, 1246 had recorded peak procedural ACT with the same point-of-care device. Periprocedural and in-hospital outcomes were compared between patients who received a total heparin dose <60 U/kg (n=2161) and ≥60 U/kg (n=2582). Similarly, outcomes were evaluated between groups with a peak procedural ACT <250 seconds (n=855) and ≥250 seconds (n=391). Technical and procedural success as well as intraprocedural thrombotic events did not differ between groups. Patients with heparin dose ≥60 U/kg had a higher rate of postprocedural hemoglobin drop ≥3 g/dL (7.09% versus 5.09%, respectively, P=0.004) and a higher transfusion rate compared with those with heparin dose <60 U/kg (4.92% versus 3.15%, respectively, P=0.002). In multivariate analysis, independent predictors of bleeding requiring transfusion were total heparin dose ≥60 U/kg, ACT ≥250 seconds, female sex, age ≥70 years, prior anemia, prior heart failure, low creatinine clearance, hybrid vascular surgery, rest pain, and below-knee intervention. In propensity-matched, risk-adjusted models and after hierarchical modeling, total heparin dose ≥60 U/kg and ACT ≥250 seconds remained strong predictors of post-PVI drop in hemoglobin ≥3 g/dL or transfusion. CONCLUSIONS: During PVI, higher total heparin dose (≥60 U/kg) and peak ACT ≥250 seconds were predictors of postprocedural transfusion. The high technical and procedural success in all groups suggests that use of weight-based heparin dosing with a target ACT <250 seconds in PVI may minimize the bleeding risk without compromising procedural success or increasing thromboembolic complications.

Development of a multicenter peripheral arterial interventional database: the PVD-QI2.

BACKGROUND: The number of peripheral vascular intervention (PVI) procedures performed is steadily increasing in the United States. PVD-QI 2 is a prospective, multicenter observational study designed to improve the quality of care for patients undergoing PVI and to better understand the effectiveness and appropriateness of PVI in improving outcomes of peripheral arterial disease. The registry aims to elucidate which comorbid conditions and procedure-related variables are associated with beneficial or adverse outcomes after vascular interventions. METHODS: Five centers are currently prospectively collecting data on consecutive PVIs performed at their institutions and will include patients with both claudication and critical limb ischemia. A common data collection form and a standard set of definitions were developed during several planning meetings. Information on patient demographics, clinical history, comorbid conditions, treatment approaches, and in hospital outcomes are being collected. Patients will be followed up at 30 days, 6 months, and 1 year after each procedure to identify recurrent vascular events, medication use, lifestyle modifications (regular exercise, dietary modification), self-reported walking scores, and mortality. Data validity will be assured through review of data form accuracy by a trained nurse, by automatic database diagnostic routines, and by site visits that include review of angiography suite logs and randomly selected charts. CONCLUSIONS: The development of a quality-controlled PVI registry requires the commitment and collaboration of clinician-investigators and hospital systems devoted to understanding factors that contribute to quality outcomes. Central to achievement of this goal is the creation of a careful diagnostic and data quality assessment system. This registry will provide important clinical insights into patient demographic and clinical characteristics, procedural characteristics, and current practice patterns that foster or impede achievement of long-term quality-based clinical outcomes for patients with peripheral arterial disease.

Missed opportunities to treat atherosclerosis in patients undergoing peripheral vascular interventions: insights from the University of Michigan Peripheral Vascular Disease Quality Improvement Initiative (PVD-QI2).

BACKGROUND: Peripheral vascular disease is a manifestation of systemic atherosclerosis and is associated with an increased risk of cardiovascular morbidity and mortality. METHODS AND RESULTS: We examined clinical outcomes in 66 consecutive patients undergoing peripheral vascular interventions at our institution between January 2001 and October 2001. At hospital discharge and at 6 months, lifestyle modifications and use of evidence-based therapy was suboptimal. At 6 months, a significant proportion continued to smoke (22.7%) and only half of the patients exercised, controlled their weight, or modified their diet for lipid control. The use of antiplatelet therapy was 77.2%; of angiotensin-converting enzyme, 35.9%; of beta-blockers, 42.5%; and of statins, 50%. Twelve of the 66 patients (18.2%) had a clinical event of death, myocardial infarction, or stroke. An appropriateness algorithm for use of secondary prevention measures was created with the use of evidence-based therapy guidelines, and a composite appropriateness variable was also created. The use of evidence-based therapy was associated with a significant reduction of the composite of death, myocardial infarction, and stroke at 6 months (OR 0.02, 95% CI 0.01 to 0.44, P=0.01). CONCLUSIONS: Atherosclerosis risk factors are very prevalent in patients with peripheral vascular disease, but these patients receive less than optimal treatment after a predominantly technical vascular intervention. Effective secondary prevention with appropriate lifestyle interventions and evidence-based medical therapy needs to be strongly encouraged and implemented in these patients.