Late outcomes after intervention of vein grafts in diabetics with abciximab use.

OBJECTIVES: We sought to evaluate late clinical outcomes following elective percutaneous coronary interventions for saphenous vein graft with planned abciximab use in diabetics. BACKGROUND: Diabetes adversely affects long-term outcomes after percutaneous coronary intervention including percutaneous coronary intervention of saphenous vein grafts. Glycoprotein IIb/IIIa inhibitors reduce adverse outcomes of native vessel percutaneous coronary intervention in diabetics; however, their effects in diabetic patients undergoing percutaneous coronary interventions of saphenous vein grafts is not known. METHODS: We evaluated 509 elective percutaneous coronary interventions of saphenous vein grafts. Glycoprotein IIb/IIIa inhibitors were used in 99% of the percutaneous coronary interventions. Distal protection devices were not used. Clinical follow-up (mean 30+/-20 months) was available in 369/397 (93%). RESULTS: Overall, procedural success rate was 97% and was similar for diabetics and non-diabetics. Procedural major adverse cardiac events occurred in 4.8% diabetics, and 4.1% non-diabetics (p = NS). Late outcomes were similar for diabetics and non-diabetics with major adverse cardiac event rates of 57.6%, and 54.9%, respectively, p=NS. Multivariate logistic regression identified graft age and the presence of thrombus as predictors of increased late major adverse cardiac events. CONCLUSIONS: Following routine use of abciximab, late outcomes after percutaneous coronary interventions of saphenous vein grafts were similar for diabetics and non-diabetics suggesting that the historically observed adverse effect of diabetes on late outcomes after percutaneous coronary interventions of saphenous vein grafts may be attenuated by glycoprotein IIb/IIIa use. Selective use of glycoprotein IIb/IIIa inhibitor should be considered for diabetics undergoing percutaneous coronary interventions of saphenous vein grafts.

Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization.

OBJECTIVES: The study assessed clinical outcomes of closure device use following percutaneous coronary revascularization using current standards of anticoagulation and antiplatelet therapy. BACKGROUND: Evaluation of the outcomes of patients by use of vascular closure devices during coronary interventions employing current standards of anticoagulation and glycoprotein (GP) IIb/IIIa inhibitor therapy is limited. METHODS: We evaluated outcomes of 4,525 consecutive patients who underwent percutaneous coronary intervention between July 1997 and April 2000. All patients received anticoagulation with heparin and GP IIb/IIIa inhibitor therapy with abciximab. The closure method was manual in 1,824 patients, Angioseal in 524 patients and Perclose in 2,177 patients. Procedural and hospital vascular outcomes were evaluated. RESULTS: Closure device success was 97.1% Angioseal and 94.1% Perclose (p < 0.05). Minor vascular complications occurred in 1.8% of manual patients, 1.1% of Angioseal patients and 1.2% of Perclose patients (p = NS); major complications occurred in 1.3% of manual patients, 1.1% of Angioseal patients and 1.0% of Perclose patients (p = NS). Multivariate logistic regression identified only closure device failure as an independent predictor of a vascular complication. In patients with successful closure with a device, minor complications (0.8% vs. 1.8%, p < 0.05) and any complication (1.5% vs. 2.5%, p < 0.05) were reduced compared to manual compression. CONCLUSIONS: Arterial closure following coronary interventions using anticoagulation and GP IIb/IIIa inhibitor therapy can be safely and effectively performed, with vascular complication rates similar to or lower than with manual pressure. Additionally, vascular complication rates using GP IIb/IIIa inhibitor therapy regardless of the method of arterial closure are equivalent to or lower than previously published rates of vascular complications.

Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 to 2007.

OBJECTIVES: This study sought to evaluate trends in vascular complications after diagnostic cardiac catheterization (CATH) and percutaneous coronary intervention (PCI) from the femoral artery from 1998 to 2007. BACKGROUND: Vascular complications have been recognized as an important factor in morbidity after CATH and PCI. Whether strategies to reduce vascular complications performed from the femoral artery in the past decade have improved the safety of these procedures, however, is uncertain. METHODS: A total of 35,016 consecutive diagnostic cardiac catheterization (n = 20,777) and percutaneous coronary intervention procedures (n = 14,239) performed via a femoral access at a single site (Wake Forest University Baptist Medical Center) between 1998 and 2007 were evaluated. Annual rates of vascular complications were evaluated. Covariate effects on the risk of vascular complications were evaluated by logistic regression and risk-adjusted trend analysis. RESULTS: Overall, the incidence of any vascular complication decreased significantly for CATH, 1.7% versus 0.2%, and PCI, 3.1% versus 1.0%, from 1998 to 2007, both p < 0.001 for trend. Favorable trends in procedural covariates affecting vascular complications were mainly responsible for the decrease in the incidence of vascular complications, including fewer closure device failures and use of smaller sheath sizes. CONCLUSIONS: In this large, single-center, contemporary observational study, the safety of CATH and PCI performed from the femoral artery improved significantly from 1998 to 2007. Reductions in the prevalence of adverse procedural factors contributed to the decrease in the incidence of vascular complications, suggesting that strategies to reduce vascular complications can be effective in improving the safety of these procedures.

Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention using thrombin hemostatic patch-facilitated manual compression.

OBJECTIVES: To evaluate the adjusted risk of vascular complications after thrombin hemostasis patch-facilitated manual compression (THP-MC) for femoral artery access site management. BACKGROUND: Thrombin hemostatic patches shorten time to hemostasis after cardiac procedures involving femoral artery access, but whether these patches are as safe as manual compression remains uncertain. METHODS: THP-MC (D-Stat Dry, Vascular Solutions, Minneapolis, Minnesota) was used in 3,464 consecutive patients including 2,464 diagnostic cardiac catheterizations (CATH) and 1,000 percutaneous coronary intervention procedures (PCI) performed via a femoral access at a single site (WFUBMC). A total of 4,371 procedures including 2,956 CATH and 1,415 PCI performed prior to use of THP-MC, and treated with manual compression, served as the control group. Ambulation was permitted 2 to 3 hours after THP-MC, and 3 to 8 hours after MC. Propensity to receive a THP was calculated, and adjusted in-hospital outcomes evaluated. RESULTS: Time to hemostasis was similar for THP-MC (13.0 +/- 3.3 min) compared to MC (14.4 +/- 5.7 min), p = 0.51 for CATH, and was shorter for THP-MC (14.2 +/- 5.4 minutes) compared to MC (20.1 +/- 5.4 min), p <0.001, for PCI. Overall, the unadjusted incidence of any vascular complication (VC) was 0.6+/- for THP-MC and 1.0% for manual compression, p = 0.036. The propensity score-adjusted odds ratio for any VC comparing THP-MC to manual compression was 0.58 (0.34 to 0.99) for all procedures, 0.42 (0.20 to 0.87) for diagnostic procedures and 0.86 (0.39 to 1.88) for PCI. CONCLUSIONS: In this large, single-center, contemporary observational study, use of THP-MC shortened manual compression time for PCI procedures, permitted early ambulation and was as safe as conventional manual compression.

Vascular complications in women after catheterization and percutaneous coronary intervention 1998-2005.

BACKGROUND: Previous studies have indicated that women experience more vascular complications after cardiac catheterization (CATH) and percutaneous coronary intervention (PCI) than men. Whether awareness of this gender risk or implementation of strategies to reduce the overall incidence of vascular complications has had an effect on the incidence of vascular complications in women is unknown. METHODS: A total of 31,035 consecutive diagnostic CATH (n = 18,467) and PCI procedures (n = 12,568) performed via femoral access at a single site (WFUBMC) between 1998 and 2005 were evaluated. The relative incidence of vascular complications was evaluated by logistic regression models adjusted for baseline covariates. RESULTS: For the entire study period, the unadjusted incidence of any vascular complication was 2.0% for women and 1.0% for men; p < 0.05. The risk-adjusted odds ratio for any vascular complication comparing women to men for the entire study period was 1.75 (95% CI 1.37-2.23) for all procedures, 1.66 (1.17-2.36) for CATH, and 1.83 (1.32-2.54) for PCI. However, the incidence of vascular complications fell for women during the study period; p < 0.001 for trend. In 2005, the adjusted relative risk of any vascular complications in women was not significantly higher than for men OR 0.98 (0.33-2.87). CONCLUSION: In this large, single-center, contemporary observational study, female gender was the strongest independent predictor of any vascular complication after CATH and PCI. However, the incidence of vascular complications in women decreased over the 8-year study period, and the increased risk of vascular complications in women compared to men was no longer present in 2005.

Medicine at the medical center then and now: one hundred years of progress.

The health and life expectancy of persons residing in the United States has improved dramatically during the 20th century. The average life span in the US has increased by more than 30 years since 1900. This significant gain is attributable to improvements in both public health and medical care. Tempering this notable achievement is the observation that the mortality rate per 1,000 population, although showing a significant decline in the era from 1920 to 1940, has now plateaued, and may be showing a slight increase. Our scientists and physicians have appropriately exploited the scientific discoveries of the 20th century and are poised as a medical tour de force for the 21st century. The decline in deaths from coronary artery disease and stroke has resulted from risk-factor modification and the innovations of surgeons and physicians who have dedicated themselves to early detection and better treatment of these cases. During the 1960s, patients admitted to our medical center with advanced Hodgkin's disease, hairy cell leukemia, and the acute leukemias had a life expectancy of < 1 year. Today, even advanced Hodgkin's disease and hairy cell leukemia are curable, and many patients with other acute leukemias respond to therapy and have very durable remissions. The rate of maternal mortality has shown a dramatic decline, and many childhood diseases have been eradicated or reduced to infrequent occurrences. Our public health scientists and physicians are joining forces to further diminish the morbidity and mortality rates for many of our common diseases. The achievements of our past afford us the vision for what we can become.

Restick following initial Angioseal use.

The Angioseal hemostatic device is currently in widespread use for arterial closure after both diagnostic and interventional procedures. Resticking of the artery in which an Angioseal device has been placed has been discouraged for up to 90 days after the initial device placement because of theoretical concerns of disruption or dislodgment of the hemostatic plug. However, no data are available to address this concern. We evaluated the incidence of vascular complications following restick of the artery in which an Angioseal device had been deployed