Michael J. Mack M.D.

Grover, F. L., S. Vemulapalli, J. D. Carroll, F. H. Edwards, M. J. Mack, V. H. Thourani, R. G. Brindis, D. M. Shahian, C. E. Ruiz, J. P. Jacobs, G. Hanzel, J. E. Bavaria, E. M. Tuzcu, E. D. Peterson, S. Fitzgerald, M. Kourtis, J. Michaels, B. Christensen, W. F. Seward, K. Hewitt and D. R. Holmes, Jr. (2017). “2016 annual report of the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry.” J Am Coll Cardiol 69(10): 1215-1230.

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BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. RESULTS: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade

Lansky, A. J., S. R. Messe, A. M. Brickman, M. Dwyer, H. B. van der Worp, R. M. Lazar, C. G. Pietras, K. J. Abrams, E. McFadden, N. H. Petersen, J. Browndyke, B. Prendergast, V. G. Ng, D. E. Cutlip, S. Kapadia, M. W. Krucoff, A. Linke, C. S. Moy, J. Schofer, G. A. van Es, R. Virmani, J. Popma, M. K. Parides, S. Kodali, M. Bilello, R. Zivadinov, J. Akar, K. L. Furie, D. Gress, S. Voros, J. Moses, D. Greer, J. K. Forrest, D. Holmes, A. P. Kappetein, M. Mack and A. Baumbach (2017). “Proposed standardized neurological endpoints for cardiovascular clinical trials: An academic research consortium initiative.” J Am Coll Cardiol 69(6): 679-691.

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Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Grover, F. L., S. Vemulapalli, J. D. Carroll, F. H. Edwards, M. J. Mack, V. H. Thourani, R. G. Brindis, D. M. Shahian, C. E. Ruiz, J. P. Jacobs, G. Hanzel, J. E. Bavaria, E. M. Tuzcu, E. D. Peterson, S. Fitzgerald, M. Kourtis, J. Michaels, B. Christensen, W. F. Seward, K. Hewitt and D. R. Holmes, Jr. (2017). “2016 annual report of the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry.” Ann Thorac Surg 103(3): 1021-1035.

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BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. RESULTS: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade

Arnold, S. V., J. A. Spertus, S. Vemulapalli, Z. Li, R. A. Matsouaka, S. J. Baron, A. N. Vora, M. J. Mack, M. R. Reynolds, J. S. Rumsfeld and D. J. Cohen (2017). “Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population: A report from the sts/acc transcatheter valve therapy registry.” JAMA Cardiol: 2017 Feb [Epub ahead of print].

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Importance: In clinical trials, transcatheter aortic valve replacement (TAVR) has been shown to improve symptoms and quality of life. As this technology moves into general clinical practice, evaluation of the health status outcomes among unselected patients treated with TAVR is of critical importance. Objective: To examine the short- and long-term health status outcomes of surviving patients after TAVR in the context of an unselected population. Design, Setting, and Participants: This observational cohort study included patients with severe aortic stenosis who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry from November 1, 2011, to March 31, 2016, at more than 450 clinical sites. Main Outcomes and Measures: Disease-specific health status was assessed at baseline and at 30 days and 1 year after TAVR using the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score (range, 0-100 points; higher scores indicate less symptom burden and better quality of life). Factors associated with health status at 1 year after TAVR were examined using multivariable linear regression, with adjustment for baseline health status and accounting for clustering of patients within sites. Results: The 30-day analytic sample included 31 636 patients, and the 1-year cohort included 7014 surviving patients (3454 women [49.2%] and 3560 men [50.8%]; median [interquartile range] age, 84 [78-88] years). The mean (SD) baseline KCCQ-OS score was 42.3 (23.7), indicating substantial health status impairment. Surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year, with a mean improvement in the KCCQ-OS score of 27.6 (95% CI, 27.3-27.9) points at 30 days and 31.9 (95% CI, 31.3-32.6) points at 1 year. Worse baseline health status, older age, higher ejection fraction, lung disease, home oxygen use, lower mean aortic valve gradients, prior stroke, diabetes, pacemaker use, atrial fibrillation, slow gait speed, and nonfemoral access were significantly associated with worse health status at 1 year. Overall, 62.3% of patients had a favorable outcome at 1 year (alive with reasonable quality of life [KCCQ-OS score, >/=60] and no significant decline [>/=10 points] from baseline), with the lowest rates seen among patients with severe lung disease (51.4%), those undergoing dialysis (47.7%), or those with very poor baseline health status (49.2%). Conclusions and Relevance: In a national, contemporary clinical practice cohort of unselected patients, improvement in health status after TAVR was similar to that seen in the pivotal clinical trials. Although the health status results were favorable for most patients, approximately 1 in 3 still had a poor outcome 1 year after TAVR. Continued efforts are needed to improve patient selection and procedural/postprocedural care to maximize health status outcomes of this evolving therapy.

Arsalan, M., J. J. Squiers, M. A. Herbert, J. C. MacHannaford, T. Chamogeorgakis, S. L. Prince, B. L. Hamman, C. Knoff, D. O. Moore, K. B. Harrington, J. M. DiMaio, M. J. Mack and W. T. Brinkman (2017). “Comparison of outcomes of operative therapy for acute type a aortic dissections provided at high-volume versus low-volume medical centers in north texas.” Am J Cardiol 119(2): 323-327.

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Immediate surgery is standard therapy for acute type A aortic dissections (TAAD). Because of its low incidence, many smaller cardiac surgery programs do not routinely perform this procedure because it may negatively affect outcomes. Many high-risk, low-volume (LV) surgical procedures are now preferentially performed in reference centers. We compared the outcomes of surgery for TAAD in high-volume (HV) and LV centers in a single metropolitan area to determine the optimal setting for treatment. Thirty-five of the 37 cardiac surgery programs in the Dallas Ft. Worth metropolitan area participate in a regional consortium to measure outcomes collected in the Society of Thoracic Surgeons Adult Cardiac Database. From January 01, 2008, to December 31, 2014, 29 programs had treated TAAD. Those programs performing at least 100 operations for TAAD were considered HV centers and the others LV. Surgery for TAAD was performed in 672 patients over the 7-year study period with HV centers performing 469 of 672 (70%) of the operations. Despite similar preoperative characteristics, operative mortality was significantly lower in HV versus LV centers (14.1% vs 24.1%; p = 0.001). There was no significant difference in postoperative paralysis rates (2.6% vs 4.5%; p = 0.196), stroke rates (10.7% vs 9.4%; p = 0.623), or 30-day readmission rates (12.1% vs 15.5%; p = 0.292). An improved survival rate in HV centers was maintained over a 5-year follow-up period. Surgery for TAAD in a single large metropolitan area was most commonly performed in HV centers. In conclusion, the treatment of acute thoracic aortic dissection is recommended to be performed in reference centers because of lower early and midterm mortality.