Research Spotlight

Mack, M., M. Hamandi and A. Gopal (2018). “TAC for TAVR: What Is the Score?” JACC Cardiovasc Imaging. May 11. [Epub ahead of print].

Full text of this article.

Commentary on Development of a Risk Score Based on Aortic Calcification to Predict 1-year Mortality After Transcatheter Aortic Valve Replacement, Pierre Lantelme M.D., Ph.D., JACC: Cardiovascular Imaging, published online 16 May 2018.

Lopez, V., K. Sanchez, M. O. Killian and B. H. Eghaneyan (2018). “Depression screening and education: an examination of mental health literacy and stigma in a sample of Hispanic women.” BMC Public Health 18(1): 646.

Full text of this article.

BACKGROUND: Mental health literacy consists of knowledge of a mental disorder and of the associated stigma. Barriers to depression treatment among Hispanic populations include persistent stigma which is primarily perpetuated by inadequate disease literacy and cultural factors. U.S.-born Hispanics are more likely to have depression compared to Hispanics born in Latin America and are less likely to follow a treatment plan compared to non-Hispanic whites. Hispanic women are more likely to access treatment through a primary care provider, making it an ideal setting for early mental health interventions. METHODS: Baseline data from 319 female Hispanic patients enrolled in Project DESEO: Depression Screening and Education: Options to Reduce Barriers to Treatment, were examined. The study implemented universal screening with a self-report depression screening tool (the 9-item Patient Health Questionnaire (PHQ-9) and took place at one federally qualified health center (FQHC) over a 24-month period. The current analysis examined the relationship between four culturally adapted stigma measures and depression knowledge, and tested whether mental health literacy was comparable across education levels in a sample of Hispanic women diagnosed with depression. RESULTS: Almost two-thirds of the sample had less than a high school education. Depression knowledge scores were significantly, weakly correlated with each the Stigma Concerns About Mental Health Care (rho = – .165, p = .003), Latino Scale for Antidepressant Stigma (p = .124, p = .028), and Social Distance scores (p = .150, p = .007). Depression knowledge (F[2, 312] = 11.82, p < .001, partial eta(2) = .071), Social Distance scores (F[2, 312] = 3.34, p = .037, partial eta(2) = .021), and antidepressant medication stigma scores (F[2, 312] = 3.33, p = .037, partial eta(2) = .015) significantly varied by education category. Participants with at least some college education reported significantly greater depression knowledge and less stigma surrounding depression and medication than participants with lower education levels. CONCLUSIONS: Primary care settings are often the gateway to identifying undiagnosed mental health disorders, particularly for Hispanic women with comorbid physical health conditions. This study is unique in that it aims to examine the specific role of patient education level as a predictor of mental health literacy. For Hispanic women, understanding the mental health literacy of patients in a healthcare setting may improve quality of care through early detection of symptoms, culturally effective education and subsequent engagement in treatment. TRIAL REGISTRATION: NCT02491034, July 2, 2015.

Lima, B., A. Bansal, J. Abraham, J. D. Rich, S. S. Lee, B. Soleimani, J. N. Katz, A. Kilic, J. S. Young, C. B. Patel and S. M. Joseph (2018). “Controversies and Challenges of Ventricular Assist Device Therapy.” Am J Cardiol 121(10): 1219-1224.

Full text of this article.

Left ventricular assist device (LVAD) therapy has emerged as an increasingly vital facet of the treatment algorithm for advanced heart failure. Growing experience with LVAD support has led to substantial improvements in outcomes, with 1-year survival rates approaching that of cardiac transplantation. These therapeutic refinements have engendered growing interests in the potential for expanding the clinical indications for LVAD therapy to patients with less advanced heart failure. The primary obstacles to this evolution of care center largely on the prevention and/or management of the adverse events associated with LVAD therapy along with patient preference. Many programs also face the mounting difficulty of balancing quality outcomes with the increased volume of implants. During the recently assembled Users Meeting organized by St. Jude Medical, heart failure clinicians from nearly 50 LVAD implanting centers discussed these and other challenges and controversies impacting the field. The present review summarizes the key insights gleaned from this meeting.

Liau, L. M., K. Ashkan, D. D. Tran, J. L. Campian, J. E. Trusheim, C. S. Cobbs, J. A. Heth, M. Salacz, S. Taylor, S. D. D’Andre, F. M. Iwamoto, E. J. Dropcho, Y. A. Moshel, K. A. Walter, C. P. Pillainayagam, R. Aiken, R. Chaudhary, S. A. Goldlust, D. A. Bota, P. Duic, J. Grewal, H. Elinzano, S. A. Toms, K. O. Lillehei, T. Mikkelsen, T. Walpert, S. R. Abram, A. J. Brenner, S. Brem, M. G. Ewend, S. Khagi, J. Portnow, L. J. Kim, W. G. Loudon, R. C. Thompson, D. E. Avigan, K. L. Fink, F. J. Geoffroy, S. Lindhorst, J. Lutzky, A. E. Sloan, G. Schackert, D. Krex, H. J. Meisel, J. Wu, R. P. Davis, C. Duma, A. B. Etame, D. Mathieu, S. Kesari, D. Piccioni, M. Westphal, D. S. Baskin, P. Z. New, M. Lacroix, S. A. May, T. J. Pluard, V. Tse, R. M. Green, J. L. Villano, M. Pearlman, K. Petrecca, M. Schulder, L. P. Taylor, A. E. Maida, R. M. Prins, T. F. Cloughesy, P. Mulholland and M. L. Bosch (2018). “First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma.” J Transl Med 16(1): 142.

Full text of this article.

BACKGROUND: Standard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax((R))-L) to standard therapy for newly diagnosed glioblastoma. METHODS: After surgery and chemoradiotherapy, patients were randomized (2:1) to receive temozolomide plus DCVax-L (n = 232) or temozolomide and placebo (n = 99). Following recurrence, all patients were allowed to receive DCVax-L, without unblinding. The primary endpoint was progression free survival (PFS); the secondary endpoint was overall survival (OS). RESULTS: For the intent-to-treat (ITT) population (n = 331), median OS (mOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n = 131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%. As of this analysis, 223 patients are >/= 30 months past their surgery date; 67 of these (30.0%) have lived >/= 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are >/= 36 months past surgery; 44 of these (24.2%) have lived >/= 36 months and have a KM-derived mOS of 88.2 months. A population of extended survivors (n = 100) with mOS of 40.5 months, not explained by known prognostic factors, will be analyzed further. Only 2.1% of ITT patients (n = 7) had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine. Overall adverse events with DCVax were comparable to standard therapy alone. CONCLUSIONS: Addition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients, and may extend survival. Trial registration Funded by Northwest Biotherapeutics; Clinicaltrials.gov number: NCT00045968.

Lansky, A. J., S. R. Messe, A. M. Brickman, M. Dwyer, H. Bart van der Worp, R. M. Lazar, C. G. Pietras, K. J. Abrams, E. McFadden, N. H. Petersen, J. Browndyke, B. Prendergast, V. G. Ng, D. E. Cutlip, S. Kapadia, M. W. Krucoff, A. Linke, C. Scala Moy, J. Schofer, G. A. van Es, R. Virmani, J. Popma, M. K. Parides, S. Kodali, M. Bilello, R. Zivadinov, J. Akar, K. L. Furie, D. Gress, S. Voros, J. Moses, D. Greer, J. K. Forrest, D. Holmes, A. P. Kappetein, M. Mack and A. Baumbach (2018). “Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.” Eur Heart J 39(19): 1687-1697.

Full text of this article.

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.