Delayed removal of a percutaneous left ventricular assist device for patients undergoing catheter ablation of ventricular tachycardia is associated with increased 90-day mortality.

PURPOSE: Assess if timing of removal of a percutaneous left ventricular assist device (pLVAD) after ventricular tachycardia (VT) ablation alters patient outcomes. METHODS: Sixty-nine patients underwent pLVAD support. Patients were divided into early (< 24 h, n = 43) and delayed (≥ 24 h, n = 26) removal groups after ablation. Factors for delayed pLVAD removal and predictors of 90-day mortality were analyzed. RESULTS: The delayed removal group had lower LVEF (27.1 ± 9.3% vs. 20.6 ± 5.4%, p = 0.002), greater percentage LVEF < 25% (58.1% vs. 84.6%, p = 0.02), and more VT storm (41.9% vs. 96.2%, p < 0.001). Ventricular fibrillation (VF) was induced in 9/69 (13%), with incidence higher in delayed removal group (27% vs. 5%, p = 0.002). VT storm (OR = 34.72, 95% CI, 4.30-280.33; p = 0.001), LVEF < 25% (OR = 3.95, 95% CI, 1.16-13.48; p = 0.03), and VF induced during ablation (OR = 9.25, 95% CI, 1.71-50.0; p = 0.01) were associated with delayed pLVAD removal in univariate analysis. Delayed pLVAD removal had a significantly higher 90-day mortality rate (2.3% vs 30.2%; p < 0.001). Univariate Cox proportional hazard regression analysis revealed delayed pLVAD removal was a significant predictor of 90-day mortality. CONCLUSIONS: Prolonged pLVAD insertion (≥ 24 h) after VT ablation was associated with VT storm, LVEF < 25%, and VF induced during ablation. Delayed pLVAD removal was a significant predictor of 90-day mortality in patients undergoing VT ablation.

Combined LDL and VLDL Electronegativity Correlates with Coronary Heart Disease Risk in Asymptomatic Individuals.

The most electronegative constituents of human plasma LDL (i.e., L5) and VLDL (i.e., V5) are highly atherogenic. We determined whether the combined electronegativity of L5 and V5 (i.e., L5 + V5) plays a role in coronary heart disease (CHD). In 33 asymptomatic individuals (ages 32-64), 10-year hard CHD risk correlated with age (r = 0.42, p = 0.01). However, in age-adjusted analyses, 10-year hard CHD risk correlated with L5 + V5 plasma concentration (r = 0.43, p = 0.01) but not age (p = 0.74). L5 + V5 plasma concentration was significantly greater in the group with high CHD risk (39.4 ± 22.0 mg/dL; n = 17) than in the group with low CHD risk (16.9 ± 14.8 mg/dL; n = 16; p = 0.01). In cultured human aortic endothelial cells, L5 + V5 treatment induced significantly more senescence-associated-ß-Gal activity than did equal concentrations of L1 + V1 (n = 4, p < 0.001). To evaluate the in vivo relevance of these findings, we fed ApoE-/- and wild-type mice with a high-fat diet and found that plasma LDL, VLDL, and LDL + VLDL from ApoE-/- mice exhibited significantly greater electrophoretic mobility than did wild-type counterparts (n = 6, p < 0.01). The increased electronegativity of LDL and VLDL in ApoE-/- mice was accompanied by increased aortic lipid accumulation and cellular senescence (n = 6, p < 0.05). Clinical trials are warranted to test the predictive value of L5 + V5 concentration in patients with CHD.

Budget negotiation for industry-sponsored clinical trials.

The specialty of anesthesia is well suited to attract industry-sponsored clinical trials and research revenues because of its fundamental contributions to surgery, critical care, and pain medicine. However, the performance and budgeting of industry-sponsored clinical research over the past decade has been significantly altered by the rapid growth of commercially oriented networks of contract-research organizations and site-management organizations. Further, the competitive nature of today's clinical research climate can make the planning and negotiating of study budgets and contracts stressful, time consuming, frustrating, and full of pitfalls. Because a clinical trial contract is a fixed-price agreement, investigators are obligated to perform the work described in the contract, even if the actual costs exceed the study contract. Successful budgeting for the performance of an industry-sponsored clinical trial thus requires a thorough understanding of the direct and indirect costs associated with performing clinical research. We reviewed budget and contractual considerations for the successful negotiation and performance of industry-sponsored clinical research.