Research Spotlight

Mack, M. J. and L. G. Svensson (2018). “Transcatheter Aortic Valve Replacement Without On-Site Cardiac Surgery: A Disappointing Step Backward!” JACC Cardiovasc Interv 11(21): 2168-2171.

Full text of this article.

Objectives: This study sought to evaluate whether a multimarker approach might identify patients with higher mortality and hospitalization rates after aortic valve replacement (AVR) for aortic stenosis (AS). Background: The society valve guidelines include accepted triggers for AVR in patients with severe asymptomatic AS, but circulating biomarkers do not have a clear role. Method: From a prospective registry of patients undergoing cardiac surgery between 2000 and 2012, 665 treated with surgical AVR (441 isolated) were evaluated. Seven biomarkers were measured on blood samples obtained before AVR. Biomarker levels were adjusted to account for the influence of age, sex, body mass index, and renal function; the median was used to determine an elevated value. Endpoints included all-cause mortality and all-cause and cardiovascular hospitalizations. Mean follow-up was 10.7 years and 299 (45%) died. Results: Patients with 0 to 1, 2 to 3, 4 to 6, and 7 biomarkers elevated had 5-year mortality of 10%, 12%, 24%, and 33%, respectively, and 10-year mortality of 24%, 35%, 58%, and 71%, respectively (log-rank p < 0.001). The association between an increasing number of elevated biomarkers and increased all-cause mortality was observed among those with minimal symptoms (New York Heart Association functional class I or II) and those with a low N-terminal pro–B-type natriuretic peptide (p < 0.01 for both). Compared with those with 0 to 1 biomarkers elevated, patients with 4 to 6 or 7 biomarkers elevated had an increased hazard of mortality after adjustment for clinical risk scores (p < 0.01) and a 2- to 3-fold higher rate of all-cause and cardiovascular rehospitalization after AVR. Similar findings were obtained when evaluating cardiovascular mortality. Among patients with no or minimal symptoms, 42% had ≥4 biomarkers elevated. Conclusions: Among patients with severe AS treated with surgical AVR, an increasing number of elevated biomarkers of cardiovascular stress was associated with higher all-cause and cardiovascular mortality and a higher rate of repeat hospitalization. A multimarker approach may be useful in the surveillance of asymptomatic patients with severe AS to optimize surgical timing.

Kopecky, S. L. and W. C. Roberts (2018). “Stephen Louis Kopecky, MD: A Conversation With the Editor.” Am J Cardiol 122(11): 1977-1987.

Full text of this article.

Dr. Steve Kopecky was born in 1954 in San Antonio, Texas, and that is where he grew up. Both his parents were physicians, his father a cardiologist, and his mother a general practitioner. He began college at Tulane University in New Orleans and completed his college at Trinity University in San Antonio. From there it was to the University of Texas Medical School at Houston. His training in internal medicine and cardiology was entirely at the Mayo Clinic in Rochester, Minnesota, and after completion of that training he returned to San Antonio to a cardiology practice with his father and another partner. After 2 years he returned to the Mayo Clinic in Rochester and he has been there ever since. For the first 10 to 15 years on the Mayo Clinic staff, Dr. Kopecky was an interventionalist in the cardiac catheterization laboratory and also staffed the coronary care unit. In his mid-forties, he became quite interested in preventive cardiology and moved entirely into that arena and has remained as Mayo’s leader in that area. Dr. Kopecky has approximately 125 publications in prominent peer-reviewed medical journals, and he has spoken in most major medical centers in the USA and in numerous ones abroad. (Excerpt from text, p. 1977; no abstract available.)E

Kobashigawa, J., D. Dadhania, S. Bhorade, D. Adey, J. Berger, G. Bhat, M. Budev, A. Duarte-Rojo, M. Dunn, S. Hall, M. N. Harhay, K. L. Johansen, S. Joseph, C. C. Kennedy, E. Kransdorf, K. L. Lentine, R. J. Lynch, M. McAdams-DeMarco, S. Nagai, M. Olymbios, J. Patel, S. Pinney, J. Schaenman, D. L. Segev, P. Shah, L. G. Singer, J. P. Singer, C. Sonnenday, P. Tandon, E. Tapper, S. G. Tullius, M. Wilson, M. Zamora and J. C. Lai (2018). “Report from the American Society of Transplantation on Frailty in Solid Organ Transplantation.” Am J Transplant Dec 1. [Epub ahead of print].

Full text of this article.

A consensus conference on frailty in kidney, liver, heart and lung transplantation, sponsored by the American Society of Transplantation (AST) and endorsed by the American Society of Nephrology (ASN), the American Society of Transplant Surgeons (ASTS) and the Canadian Society of Transplantation (CST), took place on February 11, 2018 in Phoenix, Arizona. Input from the transplant community through scheduled conference calls enabled wide discussion of current concepts in frailty, exploration of best practices for frailty risk assessment of transplant candidates and for management after transplant, and development of ideas for future research. A current understanding of frailty was compiled by each of the solid organ groups and is presented in this paper. Frailty is a common entity in patients with end-stage organ disease who are awaiting organ transplantation, and affects mortality on the wait-list and in the post-transplant period. The optimal methods by which frailty should be measured in each organ group are yet to be determined, but studies are underway. Interventions to reverse frailty vary among organ groups and appear promising. This conference achieved its intent to highlight the importance of frailty in organ transplantation and to plant the seeds for further discussion and research in this field.

Kapadia, S. R., C. P. Huded, S. K. Kodali, L. G. Svensson, E. M. Tuzcu, S. J. Baron, D. J. Cohen, D. C. Miller, V. H. Thourani, H. C. Herrmann, M. J. Mack, M. Szerlip, R. R. Makkar, J. G. Webb, C. R. Smith, J. Rajeswaran, E. H. Blackstone and M. B. Leon (2018). “Stroke After Surgical Versus Transfemoral Transcatheter Aortic Valve Replacement in the PARTNER Trial.” J Am Coll Cardiol 72(20): 2415-2426.

Full text of this article.

BACKGROUND: Transfemoral-transcatheter aortic valve replacement (TF-TAVR) is increasingly used to treat aortic stenosis, but risk of post-procedure stroke is uncertain. OBJECTIVES: The purpose of this study was to assess stroke risk and its association with quality of life after surgical aortic valve replacement (SAVR) versus TF-TAVR. METHODS: The authors performed a propensity-matched study of 1,204 pairs of patients with severe aortic stenosis treated with SAVR versus TF-TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valves) trials from April 2007 to October 2014. Outcomes were: 1) 30-day neurological events; 2) time-varying risk of neurological events early (

Holmes, D. R., Jr., R. Hance, T. S. Syrek Jensen, D. A. Schwartz, A. Kaplan, A. Farb, B. Zuckerman, M. Leon, J. Waklowiak, M. J. Mack and J. Shuren (2018). “The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?” JACC Cardiovasc Interv 11(21): 2220-2225.

Full text of this article.

Performance of early feasibility studies in the United States can advance the goal of evaluating the safety and effectiveness of new devices aimed at unmet clinical needs and facilitating earlier access for U.S. patients to new technology. Early feasibility studies are an important component of the 21st Century Cures Act, enacted by Congress in 2016. Although regulatory processes have improved since the introduction of the Early Feasibility Studies Program, impediments at the hospital and clinical site level remain. In this paper, the authors review these issues and outline the structure and function of a clinical site consortium designed to address the problems and improve the U.S. clinical trial ecosystem.