Michael J. Mack M.D.

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.

Mack, M. J. (2018). “Is TAVR Ready for Prime Time in Low-Risk Patients?” J Am Coll Cardiol 72(18): 2106-2108.

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Transcatheter aortic valve replacement (TAVR) has been demonstrated in randomized controlled trials (RCTs) to be superior to medical therapy in inoperable patients with severe symptomatic aortic stenosis and to be noninferior to surgical aortic valve replacement (SAVR) in high and intermediate surgical risk patients. TAVR has thus become widely accepted as the standard of care in these patient cohorts due in large part to the robust body of evidence generated by 6 RCTs. We also have some outcome data in low-risk patients from a single randomized trial, NOTION (Nordic Aortic Valve Intervention Trial; NCT01057173). There are 2 more RCTs comparing TAVR with SAVR in low surgical risk patients with 2 different devices that have now completed enrollment of approximately 2,000 patients, and the outcomes of these trials are expected to become available in early 2019 . . . With this background in mind, we now consider the study by Waksman et al. reported in this issue of the Journal. It is an observational, nonrandomized study of 200 low surgical risk patients with severe symptomatic aortic stenosis who underwent TAVR. The primary endpoint of the study is all-cause mortality at 30 days. Important exclusions included bicuspid aortic valves and unsuitability for transfemoral access. The mean age was 73.6 years, and the STS PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) was 1.8. A balloon-expandable valve, Sapien 3 (Edwards Lifesciences, Irvine, California), was used in 88.2% of the patients and a self-expanding valve, CoreValve Evolut R (Medtronic, Dublin, Ireland), in 11.8%. Notable procedural findings are that 75% of the procedures were performed without general anesthesia, all by transfemoral access, and there was 1 conversion to surgery due to coronary artery obstruction (0.5%). The 30-day results are excellent in that there was no mortality and a 0.5% stroke rate. Also of note is that there was a low incidence of the need for new permanent pacemaker implantation (5%) and a low rate of new-onset atrial fibrillation (3%), and there were 2 patients (1.0%) with a moderate-severe paravalvular leak at discharge. (Commentary on Waksman et al. 2018. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol, 72.)

Stone, G. W., J. Lindenfeld, W. T. Abraham, S. Kar, D. S. Lim, J. M. Mishell, B. Whisenant, P. A. Grayburn, M. Rinaldi, S. R. Kapadia, V. Rajagopal, I. J. Sarembock, A. Brieke, S. O. Marx, D. J. Cohen, N. J. Weissman and M. J. Mack (2018). “Transcatheter Mitral-Valve Repair in Patients with Heart Failure.” N Engl J Med Sep 23. [Epub ahead of print].

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BACKGROUND: Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral-valve repair may improve their clinical outcomes. METHODS: At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy. Patients were randomly assigned to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group). The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow-up. The primary safety end point was freedom from device-related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 88.0%. RESULTS: Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001). The rate of freedom from device-related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%; P<0.001 for comparison with the performance goal). Death from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001). CONCLUSIONS: Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy, transcatheter mitral-valve repair resulted in a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up than medical therapy alone. The rate of freedom from device-related complications exceeded a prespecified safety threshold. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079.)

Still, S., M. Szerlip and M. Mack (2018). “TAVR Vs. SAVR in Intermediate-Risk Patients: What Influences Our Choice of Therapy.” Curr Cardiol Rep 20(10): 82.

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PURPOSE OF REVIEW: To determine what influences patients and physicians to choose between transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with severe, symptomatic aortic stenosis. RECENT FINDINGS: Advances in transcatheter valve technology, techniques, and trials demonstrating non-inferiority compared to surgical aortic valve replacement (SAVR) have led to expanded eligibility of transcatheter aortic valve replacement (TAVR) to both intermediate-risk patients in clinical practice and low-risk patients in pivotal trials. Since lower-risk individuals tend to be younger and good operative candidates, concerns of valve durability, procedure-related morbidity, and patient survivability require careful consideration. Results from the PARTNER II intermediate risk trials and SURTAVI trials have given us insight into the benefits and potential risks of both treatment modalities. In this article, we review the brief yet remarkable history of TAVR and discuss its role in the treatment of intermediate-surgical-risk patients.