Associations between use of the 21-gene recurrence score assay and chemotherapy regimen selection in a statewide registry.

BACKGROUND: The 21-gene recurrence score (RS) assay predicts response to adjuvant chemotherapy in patients with early-stage, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative invasive breast cancer, but to the authors' knowledge, the role of the assay in guiding the selection of chemotherapy regimen has not been established. The current study was conducted to examine patterns of use of the RS assay for selecting chemotherapy regimens across a statewide registry from 2006 through 2013. METHODS: Demographic, pathologic, and treatment data were abstracted from medical records for 16,666 women with breast cancer who were treated at 25 hospital systems across Michigan that were participating in the Michigan Breast Oncology Quality Initiative. Treatment patterns were examined based on the RS assay test result. RESULTS: Approximately 25% of patients with lymph node-negative disease who underwent testing with the RS assay and who were treated with chemotherapy received an anthracycline-based regimen, compared with 49% of patients with lymph node-negative disease who were treated with chemotherapy and who had not undergone testing with the RS assay. Of those patients with lymph node-positive disease who underwent testing with the RS assay and who received chemotherapy, 31% received an anthracycline-based regimen. In comparison, 71% of patients with lymph node-positive, chemotherapy-treated disease who did not undergo testing received an anthracycline. From 2006 through 2013, there was a statistically significant decrease in the use of anthracycline-containing regimens in both patients with lymph node-negative and lymph node-positive disease. CONCLUSIONS: Use of anthracycline-containing chemotherapy regimens in eligible patients appears to vary with use of the RS assay, despite the lack of evidence supporting use of the assay to guide regimen selection. Results of ongoing prospective trials should help to define the role of the RS assay in this setting. Cancer 2017;123:948-56. © 2016 American Cancer Society.

Impact of sex on morbidity and mortality rates after lower extremity interventions for peripheral arterial disease: observations from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

OBJECTIVES: This study sought to examine sex-related differences in outcomes related to peripheral vascular intervention (PVI) procedures. BACKGROUND: Percutaneous PVI is frequently performed for the treatment of peripheral arterial disease (PAD). However, little is known about sex-related differences related to PVI procedures. METHODS: We assessed the impact of sex among 12,379 patients (41% female) who underwent lower extremity (LE)-PVI from 2004 to 2009 at 16 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PVI registry. Multivariate propensity-matched analyses were performed to adjust for differences in baseline characteristics, procedural indications, and comorbidities on the basis of sex. RESULTS: Compared with men, women were older and have multilevel disease and critical limb ischemia. In a propensity-matched analysis, female sex was associated with a higher rate of vascular complications, transfusions, and embolism. No differences were observed for in-hospital death, myocardial infarction, or stroke or transient ischemic attack. Technical success was more commonly achieved in women (91.2% vs. 89.1%, p = 0.014), but because of a higher complication rate, the overall procedural success rates were similar in men and women (79.7% vs. 81.6%, p = 0.08). CONCLUSIONS: Women represent a significant proportion of patients undergoing LE-PVI, have a more severe and complex disease process, and are at increased risk for adverse outcomes. Despite higher complications rates, women had similar procedural success compared with men, making PVI an effective treatment strategy among women with LE-PAD.

Safety of contemporary percutaneous peripheral arterial interventions in the elderly insights from the BMC2 PVI (Blue Cross Blue Shield of Michigan Cardiovascular Consortium Peripheral Vascular Intervention) registry.

OBJECTIVES: This study sought to evaluate the effect of age on procedure type, periprocedural management, and in-hospital outcomes of patients undergoing lower-extremity (LE) peripheral vascular intervention (PVI). BACKGROUND: Surgical therapy of peripheral arterial disease is associated with significant morbidity and mortality in the elderly. There are limited data related to the influence of advanced age on the outcome of patients undergoing percutaneous LE PVI. METHODS: Clinical presentation, comorbidities, and in-hospital outcomes of patients undergoing LE PVI in a multicenter, multidisciplinary registry were compared between 3 age groups: < 70 years, between 70 and 80 years, and ≥ 80 years (elderly group). RESULTS: In our cohort, 7,769 patients underwent LE PVI. The elderly patients were more likely to be female and to have a greater burden of comorbidities. Procedural success was lower in the elderly group (74.2% for age ≥ 80 years vs. 78% for age 70 to < 80 years and 81.4% in patients age < 70 years, respectively; p < 0.0001). Unadjusted rates of procedure-related vascular access complications, post-procedure transfusion, contrast-induced nephropathy, amputation, and major adverse cardiac events were higher in elderly patients. After adjustment for baseline covariates, the elderly patients were more likely to experience vascular access complications; however, advanced age was not found to be associated with major adverse cardiac events, transfusion, contrast-induced nephropathy, or amputation. CONCLUSIONS: Contemporary PVI can be performed in elderly patients with high procedural and technical success with low rates of periprocedural complications including mortality. These findings may support the notion of using PVI as a preferred revascularization strategy in the treatment of severe peripheral arterial disease in the elderly population.

Complication rates for percutaneous lower extremity arterial antegrade access.

HYPOTHESIS: The antegrade access (AA) for percutaneous arterial interventions is associated with a higher complication rate than is the retrograde access (RA). DESIGN: Retrospective case review. SETTING: A statewide consortium for peripheral vascular interventions consisting of 13 Michigan hospitals collecting data on their endovascular procedures. PATIENTS: Demographic and procedure data on all patients receiving a percutaneous peripheral arterial intervention were entered prospectively by a full-time clinical nurse specialist in each hospital site. MAIN OUTCOME MEASURES: We evaluated vascular complications as a composite of retroperitoneal hematoma, pseudoaneurysm, hematoma requiring blood transfusion, arteriovenous fistula, acute thrombosis, or the need for surgical repair of the access site. RESULTS: In a 2-year period, we collected 6343 cases, of which 5918 had complete data regarding arterial access; of these, 745 (12.6%) were performed via an AA. There were fewer women and smokers (P < .001) in the AA group but more diabetic patients (P < .001). The indications for intervention were more frequently rest pain (P < .001) and limb salvage (P < .001) in the AA group. Multivariate regression analysis showed that the odds of complications were significantly higher with a larger sheath (95% confidence interval, 1.53-4.06; P < .001). Also, the incidence of blood transfusion and subsequent amputation was significantly higher in the AA group (P < .001). CONCLUSION: Endovascular procedures performed via an AA are more likely to result in perioperative complications and therefore should be used cautiously.

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.