Research Spotlight

Minns, S., A. Levihn-Coon, E. Carl, J. A. J. Smits, W. Miller, D. Howard, S. Papini, S. Quiroz, E. Lee-Furman, M. Telch, P. Carlbring, D. Xanthopoulos and M. B. Powers (2018). “Immersive 3D exposure-based treatment for spider fear: A randomized controlled trial.” J Anxiety Disord Dec 20. [Epub ahead of print].

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Stereoscopic 3D gives the viewer the same shape, size, perspective and depth they would experience viewing the real world and could mimic the perceptual threat cues present in real life. This is the first study to investigate whether an immersive stereoscopic 3D video exposure-based treatment would be effective in reducing fear of spiders. Participants with a fear of spiders (N = 77) watched two psychoeducational videos with facts about spiders and phobias. They were then randomized to a treatment condition that watched a single session of a stereoscopic 3D immersive video exposure-based treatment (six 5-minute exposures) delivered through a virtual reality headset or a psychoeducation only control condition that watched a 30-minute neutral video (2D documentary) presented on a computer monitor. Assessments of spider fear (Fear of Spiders Questionnaire [FSQ], Behavioral Approach Task [BAT], & subjective ratings of fear) were completed pre- and post-treatment. Consistent with prediction, the stereoscopic 3D video condition outperformed the control condition in reducing fear of spiders showing a large between-group change effect size on the FSQ (Cohen’s d = 0.85) and a medium between-group effect size on the BAT (Cohen’s d = 0.47). This provides initial support for stereoscopic 3D video in treating phobias.

Mack, M., M. Hamandi and A. Gopal (2019). “TAC for TAVR: What Is the Score?” JACC Cardiovasc Imaging 12(1): 133-134.

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Abstract not available.

Mack, M. and M. Hamandi (2019). “Why Surgical Risk Algorithms Are Not Predictive of Transcatheter Aortic Valve Replacement Outcomes!” Circ Cardiovasc Interv 12(1): e007560.

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At least 12 risk algorithms have been constructed in various populations and differing periods to predict outcomes after surgical aortic valve replacement (SAVR). The 2 most widely used are the LES and the STS Predicted Risk of Mortality. The LES was developed in 1995 as an additive score (Additive EuroSCORE) and later converted to a logistic regression model. It was derived from a data set from 8 European countries and was based on a population sample of almost 15,000 patients undergoing all types of cardiac operations. There were 12 covariates identified that were predictive of early mortality in SAVR. The benefit of the LES is its user-friendliness, in that it requires only 18 data fields for the calculation. The shortcoming is that the algorithm is calculated on a relatively small sample size of a diverse set of cardiac operations from nearly 25 years ago. The LES has been repeatedly demonstrated to over-predict actual risk in the assessment of patients for whom surgery poses a high risk in the case of SAVR by a factor of 3. The STS Predicted Risk of Mortality has been more reflective of actual outcomes because it is SAVR specific (versus all cardiac surgical procedures) and based on more current data. An updated risk predictor, EuroSCORE II, was derived from more than 22 000 patients operated on in 2010 in 43 countries worldwide. It includes all cardiac procedures and now has 18 covariates predictive of surgical aortic valve mortality. Whether the accuracy of the EuroSCORE II model has been improved is a subject of debate. A renewed and intense interest has developed in predictive modeling for the management of patients with aortic stenosis because of the introduction of TAVR. When first introduced into clinical practice, TAVR was performed in the highest surgical risk patients. LES and STS Predicted Risk of Mortality were the 2 most common tools used for defining these high surgical risk patients and hence, were widely adopted for TAVR patient selection. However, it should not be surprising that the surgical risk scores have proven to be inaccurate for TAVR because of the fact that the risk algorithms were developed for one procedure and are being applied to a different one. Not only were the risk models neither developed nor validated for TAVR, but they do not take into consideration variables that may play a significant role in risk, including porcelain aorta, previous radiation therapy, liver disease, and frailty since the incidence of those factors were so low in the surgical population in which they were developed and validated. However, these risk scores have used because until now, because they were the best available. In 2016, a TAVR-specific risk model for in-hospital mortality was published. This model was based entirely on TAVR patients included in the STS/American College of Cardiology Transcatheter Valve Registry from 2011 to 2014. It was derived from a patient population of 13,718 and validated on 6,868 different patients in a subsequent time period. It included all commercially available valves in the United States and used 9 variables to predict in-hospital mortality with a C-statistic of 0.66. This is now in the process of being updated to predict 30-day and 1-year mortality after TAVR. (Excerpt from the introduction to, Taratini, G., et al., One-Year Outcomes of a European Transcatheter Aortic Valve Implantation Cohort According to Surgical Risk, Circ Cardiovasc Interv. 2019 Jan;12(1):e006724.)

Klintmalm, G. B., B. Kaplan and A. D. Kirk (2018). “FDA jeopardizes the lives of lung transplant recipients and in the process severely increases the cost to develop new immunosuppression.” Am J Transplant Dec 14. [Epub ahead of print].

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On January 1, 2018, Medicare Part D insurers implemented a new rule that seriously affects immunosuppression in lung transplant recipients. The program is now following the directive of the US Food and Drug Administration (FDA) that no drug should be dispensed or be covered by insurance for any indications other than those approved by the FDA.1, 2 That excludes the use of mycophenolate (CellCept and Myfortic) and azathioprine (Imuran) for lung transplant recipients. This new rule affects not only patients transplanted after January 1, 2018, but also previous lung transplant patients when they renew their Medicare Part D plan. At this point, non‐Medicare patients are not affected by these rulings. Azathioprine was approved as an immunosuppressant in 1968 for kidney transplant and has been used universally in all organ transplants since then but has never undergone a modern FDA trial. To obtain an FDA‐approved indication, a drug must undergo a phase 3 randomized trial for the specific indication. Randomized trials have never been done in lung transplant. Very few cases are performed per year: only 2405 adult cases were performed in 2017, and only 35 centers performed >25 cases that year. It would take many years with slow enrollment to produce a conclusive study with adequate follow‐up. The current FDA rules that prohibit the use of mycophenolate or azathioprine in lung transplant recipients substantially increase the likelihood that these patients will develop allograft rejection and die. Triple‐drug immunosuppression is standard in all other organs transplanted and has time and again been shown to not only improve survival but also reduce drug toxicity by allowing lower doses of the other immunosuppressants (calcineurin inhibitors and steroids). Additionally, mandating exceptionally expensive phase 3 registration trials for each different organ contributes to the prohibitive costs of drug development in the United States—one major reason why drug manufacturers now avoid performing trials in this country. This is in a time when we are seeking to reduce the cost of healthcare. There is a critical need for the FDA and Medicare to rethink their position. (Excerpt from this editorial, p. 1.)

Kanwal, F., E. B. Tapper, C. Ho, S. K. Asrani, N. Ovchinsky, J. Poterucha, A. Flores, V. Ankoma-Sey, B. Luxon and M. Volk (2018). “Development of Quality Measures in Cirrhosis by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.” Hepatology Dec 26. [Epub ahead of print].

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Health care delivery is increasingly evaluated according to quality measures, yet such measures are underdeveloped for cirrhosis. The Practice Metrics Committee of the American Association for the Study of Liver Diseases was charged with developing explicit process- and outcome-based measures for adults with cirrhosis. We identified candidate measures from comprehensive reviews of the literature and input from expert clinicians and patient focus groups. We conducted an 11-member expert clinician panel and used a modified Delphi method to systematically identify a set of quality measures in cirrhosis. Among 119 candidate measures, 46 were identified as important measures to define quality of cirrhosis care, including 26 process measures, 7 clinical outcome measures, and 13 patient-reported outcome measures. The final process measures captured care processes across the entire spectrum from diagnosis, treatment, and prevention for ascites (5 measures), varices/bleeding (7 measures), hepatic encephalopathy (4 measures), hepatocellular cancer (HCC) screening (1 measure), liver transplantation evaluation (2 measures), and other care (7 measures). Clinical outcome measures included survival, variceal bleeding and re-bleeding, early-stage HCC, liver-related hospitalization, and rehospitalization within 7 and 30 days. Patient-reported outcome measures covered physical symptoms, physical function, mental health, general function, cognition, social life, and satisfaction with care. The final list of patient-reported outcomes was validated in 79 cirrhosis patients from 9 institutions in the United States.Conclusion We developed an explicit set of evidence-based quality measures for adult patients with cirrhosis. These measures are a tool for providers and institutions to evaluate their care quality, drive quality improvement, and deliver high-value cirrhosis care. The quality measures are intended to be applicable in any clinical care setting in which care for patients with cirrhosis is provided.