Cardiology

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.

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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.

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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.

Dearani, J. A., T. K. Rosengart, M. B. Marshall, M. J. Mack, D. R. Jones, R. L. Prager and R. J. Cerfolio (2018). “Incorporating Innovation and New Technology into Cardiothoracic Surgery.” Ann Thorac Surg Nov 21. [Epub ahead of print].

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The appropriate implementation of new technology, root cause analysis of “imperfect” outcomes and the continuous reappraisal of postgraduate training are needed to improve the care of tomorrow’s patients. Healthcare delivery remains one of the most expensive sectors in the United States and the application of new and expensive technology that is necessary for the advancement of this complex specialty must be aligned with providing the best care for our patients. There are a several pathways to innovation; one is partnering with industry and the other is the investigational laboratory. Innovation and the funding thereof come from both the public and the private sector. The majority of new trials that are likely to impact cardiothoracic surgery are industry sponsored trials to meet the requirements necessary for regulatory approval. Cost considerations are paramount when considering integration of innovative technology and treatments into a clinical cardiothoracic surgical practice. The value of any new innovation is determined by the quality divided by the cost, and lean initiatives maximize this equation. The importance and implications of conflict of interest (COI) has been a concern for physicians particularly when new technology or procedures are being incorporated into clinical practice and full disclosures by medical professionals and others involved are essential. Our “societies” and “associations” provide a platform for presentation and peer-reviewed discussion of new procedures, innovations, and trials, etc. and provide a venue for the sharing of knowledge on the highest quality patient care through education and research.

Mao, J., R. F. Redberg, J. D. Carroll, D. Marinac-Dabic, J. Laschinger, V. Thourani, M. Mack and A. Sedrakyan (2018). “Association Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes.” JAMA Cardiol Oct 31. [Epub ahead of print].

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Importance: The Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited. Objective: To examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs. Design, Setting, and Participants: This observational cohort study included 60538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries. Main Outcomes and Measures: The associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined. Results: Among the 60538 patients, 29173 were women and 31365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, >/=97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89). Conclusions and Relevance: Hospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.

Rangaswami, J. and P. A. McCullough (2018). “Heart Failure in End-Stage Kidney Disease: Pathophysiology, Diagnosis, and Therapeutic Strategies.” Semin Nephrol Nov. 11: 38(6): 600-617.

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Heart failure (HF) is a major comorbidity in patients with end-stage kidney disease (ESKD). The pathogenesis of HF in patients on renal replacement therapy represents the confluence of several traditional and nontraditional vascular risk factors, unique to the milieu of chronic kidney disease and the dialysis modality. The diagnosis of HF with ESKD is complicated by the background of frequent inevitable fluid shifts superimposed on underlying myocardial pump abnormalities and dialysis-induced myocardial stunning. A careful temporal assessment of symptoms and physical findings, cardiac imaging, hemodynamic data, and biomarkers help establish an accurate diagnosis of HF in ESKD. Accurate volume assessment and its tight management remains the cornerstone of treatment in HF in patients on dialysis. A multidisciplinary approach between the cardiologist and nephrologist in optimizing pharmacologic strategies for HF in this population, and dialysis-based options such as frequent dialysis, may help reduce the burden of HF in this vulnerable population. Finally, including patients with ESKD in clinical trials for HF therapies, and designing pragmatic trials that bring targeted strategies for HF into the daily clinical practice of dialysis, will shed light on the optimal management of the dual burden of cardiomyopathy and advanced kidney disease.