Research Spotlight

Patel, M. R., J. H. Calhoon, G. J. Dehmer, J. A. Grantham, T. M. Maddox, D. J. Maron and P. K. Smith (2017). “Acc/aats/aha/ase/asnc/scai/scct/sts 2017 appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease : A report of the american college of cardiology appropriate use criteria task force, american association for thoracic surgery, american heart association, american society of echocardiography, american society of nuclear cardiology, society for cardiovascular angiography and interventions, society of cardiovascular computed tomography, and society of thoracic surgeons.” J Nucl Cardiol: 2017 Jun [Epub ahead of print].

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The American College of Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and American Association for Thoracic Surgery, along with key specialty and subspecialty societies, have completed a 2-part revision of the appropriate use criteria (AUC) for coronary revascularization. In prior coronary revascularization AUC documents, indications for revascularization in acute coronary syndromes and stable ischemic heart disease (SIHD) were combined into 1 document. To address the expanding clinical indications for coronary revascularization, and to align the subject matter with the most current American College of Cardiology/American Heart Association guidelines, the new AUC for coronary artery revascularization were separated into 2 documents addressing SIHD and acute coronary syndromes individually. This document presents the AUC for SIHD.Clinical scenarios were developed to mimic patient presentations encountered in everyday practice. These scenarios included information on symptom status; risk level as assessed by noninvasive testing; coronary disease burden; and, in some scenarios, fractional flow reserve testing, presence or absence of diabetes, and SYNTAX score. This update provides a reassessment of clinical scenarios that the writing group felt were affected by significant changes in the medical literature or gaps from prior criteria. The methodology used in this update is similar to the initial document but employs the recent modifications in the methods for developing AUC, most notably, alterations in the nomenclature for appropriate use categorization.A separate, independent rating panel scored the clinical scenarios on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization is considered appropriate for the clinical scenario presented. Scores of 1 to 3 indicate that revascularization is considered rarely appropriate for the clinical scenario, whereas scores in the mid-range of 4 to 6 indicate that coronary revascularization may be appropriate for the clinical scenario.As seen with the prior coronary revascularization AUC, revascularization in clinical scenarios with high symptom burden, high-risk features, and high coronary disease burden, as well as in patients receiving antianginal therapy, are deemed appropriate. Additionally, scenarios assessing the appropriateness of revascularization before kidney transplantation or transcatheter valve therapy are now rated. The primary objective of the AUC is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making.

Puskas, J. D., J. E. Bavaria, L. G. Svensson, E. H. Blackstone, B. Griffith, J. S. Gammie, D. A. Heimansohn, J. Sadowski, K. Bartus, D. R. Johnston, J. Rozanski, T. Rosengart, L. N. Girardi, C. T. Klodell, M. A. Mumtaz, H. Takayama, M. Halkos, V. Starnes, P. Boateng, T. A. Timek, W. Ryan, S. Omer and C. R. Smith (2017). “The commence trial: 2-year outcomes with an aortic bioprosthesis with resilia tissuedagger.” Eur J Cardiothorac Surg: 2017 Jun [Epub ahead of print].

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OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve with RESILIA tissue (Model 11000A) in a prospective, multinational, multicentre ( n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. RESULTS: Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 +/- 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 +/- 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 +/- 0.5 cm 2 ; mean gradient was 10.1 +/- 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. CONCLUSIONS: These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA).

Salisbury, D. and K. Meredith (2017). “Neuropsychological functioning following cardiac transplant in danon disease.” Dev Neurorehabil: 1-4.

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PURPOSE: To present a unique case involving a 31-year-old male with Danon disease (diagnosed at 14) who received cardiac transplant and subsequent cardiac re-transplant. RESEARCH DESIGN: Brief report/case study. METHODS: Serial neuropsychological assessment across a 23-year span along with a review of school records and prior psychoeducational assessment. RESULTS: A consistent pattern of higher level cognitive impairment from childhood through adulthood was found. This pattern is interpreted in light of the sparse literature regarding cognitive and adaptive functioning related to Danon disease. CONCLUSIONS: The noteworthy aspects of this case include the preservation of some academic abilities and an unexpected level of functional independence given cognitive concerns. This case study further explores the nature of the deficits related to Danon disease and highlights the benefits of neuropsychological evaluation to guide functional interventions and maximize level of independence across the life span.

Schadendorf, D., J. Larkin, J. Wolchok, F. S. Hodi, V. Chiarion-Sileni, R. Gonzalez, P. Rutkowski, J. J. Grob, C. L. Cowey, C. Lao, J. Wagstaff, M. K. Callahan, M. A. Postow, M. Smylie, P. F. Ferrucci, R. Dummer, A. Hill, F. Taylor, J. Sabater, D. Walker, S. Kotapati, A. Abernethy and G. V. Long (2017). “Health-related quality of life results from the phase iii checkmate 067 study.” Eur J Cancer 82: 80-91.

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BACKGROUND: Nivolumab, a monoclonal antibody of immune checkpoint programmed death 1 on T cells (PD-1), combined with ipilimumab, an immune checkpoint cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor, as combination therapy on the one hand and nivolumab as monotherapy on the other, have both demonstrated improved efficacy compared with ipilimumab alone in the CheckMate 067 study. However, the combination resulted in a higher frequency of grade 3/4 adverse events (AEs), which could result in diminished health-related quality of life (HRQoL). Here we report analyses of HRQoL for patients with advanced melanoma in clinical trial CheckMate 067. PATIENTS AND METHODS: HRQoL was assessed at weeks 1 and 5 per 6-week cycle for the first 6 months, once every 6 weeks thereafter, and at two follow-up visits using the European Organization for Research and Treatment of Care Core Quality of Life Questionnaire and the EuroQoL Five Dimensions Questionnaire. In addition to the randomised population, patient subgroups, including BRAF mutation status, partial or complete response, treatment-related AEs of grade 3/4, and those who discontinued due to any reason and due to an AE, were investigated. RESULTS: Nivolumab and ipilimumab combination and nivolumab alone both maintained HRQoL, and no clinically meaningful deterioration was observed over time compared with ipilimumab. In addition, similar results were observed across patient subgroups, and no clinically meaningful changes in HRQoL were observed during follow-up visits for patients who discontinued due to any cause. CONCLUSION: These results further support the clinical benefit of nivolumab monotherapy and nivolumab and ipilimumab combination therapy in patients with advanced melanoma. The finding that the difference in grade 3/4 AEs between the arms did not translate into clinically meaningful differences in the reported HRQoL may be relevant in the clinical setting.

Shear, N. H., R. Alhusayen, A. Fernandez-Obregon, A. B. Kimball, A. Menter, J. J. Wu, K. Goyal, H. Patel, R. Lin and A. W. Armstrong (2017). “Observations from our evaluation of body weight changes after initiation of a biologic therapy in psolar.” J Eur Acad Dermatol Venereol: 2017 Jun [Epub ahead of print].

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PSOLAR is a global, prospective, observational study designed to evaluate long-term safety and clinical outcomes for over 12,000 psoriasis patients who are receiving, or are eligible to receive, biologic and/or conventional systemic agents. Data from the registry may also be used to test hypotheses for topics of interest to dermatologists.1 While PSOLAR has produced many viable analyses of safety and efficacy outcomes, including overall safety, serious infections, comparative effectiveness, and persistence of treatment,2-5 a recently tested hypothesis related to treatment effect on body weight did not generate interpretable results. Our observations may be relevant for future research in this area.