Michael J. Mack M.D.

Mack, M. J. and R. Stoler (2017). “Intervention for aortic stenosis: The measurement of frailty matters.” J Am Coll Cardiol 70(6): 701-703.

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Frailty is a relatively common condition in patients with cardiovascular disease. This condition, which includes impairment of multiple physiological systems, occurs more frequently with advancing age and is particularly relevant when these patients undergo cardiovascular interventions or surgery. As a general rule of thumb, the more invasive the procedure and the older the patient, the more that frailty matters in terms of influencing procedure outcomes, recovery, and benefit. There are multiple risk models that have accuracy in predicting early, 30-day outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) (1 2) . Although a wide spectrum of patient factors and comorbid disease conditions are used as covariates in constructing these predictive algorithms, measures of frailty have not been routinely included. The reasons for lack of inclusion include the wide variety of tools available to measure frailty, a lack of a consensus on which tools to use, and the burden and time required to perform the tests, leading to variability and incompleteness of collection. In addition, routine use has been hampered by the lack of a solid evidence base for the measurement of frailty really having value in determining the ability of a patient to undergo a procedure successfully and withstand the associated systemic and physiological insults that may preclude full recovery. However, with the advent of less-invasive procedures, which offer treatment options to patients previously not considered candidates, measurement of frailty in the elderly population has assumed greater import. The 2014 American Heart Association/American College of Cardiology Guideline for the Management of Patients with Valvular Heart Disease (3) included frailty, major organ system dysfunction, and procedure-specific impediments as adjunctive to the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) in risk assessment in patients under consideration for treatment (4) . The tools most commonly used in current clinical evaluation of patients with aortic stenosis are the measurement of gait speed using the 5-m walk test and the Fried Criteria, which measure 4 domains of frailty, including mobility, strength, nutritional status, and habitual activity.

Mooney, J., S. L. Sellers, P. Blanke, P. Pibarot, R. T. Hahn, D. Dvir, P. S. Douglas, N. J. Weissman, S. K. Kodali, V. H. Thourani, H. Jilaihawi, O. Khalique, C. R. Smith, S. H. Kueh, M. Ohana, R. Grover, C. Naoum, A. Crowley, W. A. Jaber, M. C. Alu, R. Parvataneni, M. Mack, J. G. Webb, M. B. Leon and J. A. Leipsic (2017). “Ct-defined prosthesis-patient mismatch downgrades frequency and severity, and demonstrates no association with adverse outcomes after transcatheter aortic valve replacement.” JACC Cardiovasc Interv 10(15): 1578-1587.

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OBJECTIVES: This study sought to determine if indexed effective orifice area (EOAi), using left ventricular outflow tract measured from computed tomography (EOAiCT), reclassified prosthesis-patient mismatch (PPM) compared with conventional echocardiogram-defined measurements (EOAiTTE). BACKGROUND: PPM does not predict mortality following transcatheter aortic valve replacement (TAVR). However, it is unknown if the EOAiCT of the left ventricular outflow tract improves risk stratification. METHODS: A total of 765 TAVR patients from the PARTNER II (Placement of Aortic Transcatheter Valves II) trial S3i cohort were evaluated. EOAi was calculated using the continuity equation, and the left ventricular outflow tract area was derived from baseline computed tomography. Traditional echocardiographic categories defined PPM: absent (>0.85 cm2/m2), moderate (>/=0.65 and

Brennan, J. M., L. Thomas, D. J. Cohen, D. Shahian, A. Wang, M. J. Mack, D. R. Holmes, F. H. Edwards, N. Z. Frankel, S. J. Baron, J. Carroll, V. Thourani, E. M. Tuzcu, S. V. Arnold, R. Cohn, T. Maser, B. Schawe, S. Strong, A. Stickfort, E. Patrick-Lake, F. L. Graham, D. Dai, F. Li, R. A. Matsouaka, S. O’Brien, F. Li, M. J. Pencina and E. D. Peterson (2017). “Transcatheter versus surgical aortic valve replacement: Propensity-matched comparison.” J Am Coll Cardiol 70(4): 439-450.

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BACKGROUND: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. OBJECTIVES: The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort. METHODS: Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score >/=3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities. RESULTS: In a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients. CONCLUSIONS: Among unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.

Mooney, J., S. L. Sellers, P. Blanke, P. Pibarot, R. T. Hahn, D. Dvir, P. S. Douglas, N. J. Weissman, S. K. Kodali, V. H. Thourani, H. Jilaihawi, O. Khalique, C. R. Smith, S. H. Kueh, M. Ohana, R. Grover, C. Naoum, A. Crowley, W. A. Jaber, M. C. Alu, R. Parvataneni, M. Mack, J. G. Webb, M. B. Leon and J. A. Leipsic (2017). “Ct-defined prosthesis-patient mismatch downgrades frequency and severity, and demonstrates no association with adverse outcomes after tavr.” JACC Cardiovasc Interv: 2017 Jul [Epub ahead of print].

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OBJECTIVES: This study sought to determine if indexed effective orifice area (EOAi), using left ventricular outflow tract measured from computed tomography (EOAiCT), reclassified prosthesis-patient mismatch (PPM) compared with conventional echocardiogram-defined measurements (EOAiTTE). BACKGROUND: PPM does not predict mortality following transcatheter aortic valve replacement (TAVR). However, it is unknown if the EOAiCT of the left ventricular outflow tract improves risk stratification. METHODS: A total of 765 TAVR patients from the PARTNER II (Placement of Aortic Transcatheter Valves II) trial S3i cohort were evaluated. EOAi was calculated using the continuity equation, and the left ventricular outflow tract area was derived from baseline computed tomography. Traditional echocardiographic categories defined PPM: absent (>0.85 cm2/m2), moderate (>/=0.65 and

Baron, S. J., S. V. Arnold, K. Wang, E. A. Magnuson, K. Chinnakondepali, R. Makkar, H. C. Herrmann, S. Kodali, V. H. Thourani, S. Kapadia, L. Svensson, D. L. Brown, M. J. Mack, C. R. Smith, M. B. Leon and D. J. Cohen (2017). “Health status benefits of transcatheter vs surgical aortic valve replacement in patients with severe aortic stenosis at intermediate surgical risk: Results from the partner 2 randomized clinical trial.” JAMA Cardiol: 2017 Jun [Epub ahead of print].

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Importance: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown. Objective: To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR. Design, Setting, and Participants: Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017. Main Outcomes and Measures: Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status. Results: Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better health status than SAVR, but this difference was restricted to patients treated via transfemoral access (mean difference in the KCCQ overall summary [KCCQ-OS] score, 14.1 points; 95% CI, 11.7 to 16.4; P < .01) and was not seen in patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, -1.4 to 8.4; P < .01 for interaction). There were no significant differences between TAVR and SAVR in any health status measures at 1 or 2 years. Conclusions and Relevance: Among intermediate-risk patients with severe AS, health status improved significantly with both TAVR and SAVR through 2 years of follow up. Early health status improvement was greater with TAVR, but only among patients treated via transfemoral access. Longer term follow-up is needed to assess the durability of quality-of-life improvement with TAVR vs SAVR in this population.