Michael J. Mack M.D.

Makkar, R. R., V. H. Thourani, M. J. Mack, S. K. Kodali, S. Kapadia, J. G. Webb, S. H. Yoon, A. Trento, L. G. Svensson, H. C. Herrmann, W. Y. Szeto, D. C. Miller, L. Satler, D. J. Cohen, T. M. Dewey, V. Babaliaros, M. R. Williams, D. J. Kereiakes, A. Zajarias, K. L. Greason, B. K. Whisenant, R. W. Hodson, D. L. Brown, W. F. Fearon, M. J. Russo, P. Pibarot, R. T. Hahn, W. A. Jaber, E. Rogers, K. Xu, J. Wheeler, M. C. Alu, C. R. Smith and M. B. Leon (2020). “Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.” New England Journal of Medicine 382(9): 1-11.

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BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Kiani, S., A. Stebbins, V. H. Thourani, J. Forcillo, S. Vemulapalli, A. S. Kosinski, V. Babaliaros, D. Cohen, S. K. Kodali, A. J. Kirtane, J. B. Hermiller, Jr., J. Stewart, A. Lowenstern, M. J. Mack, R. A. Guyton and C. Devireddy (2020). “The Effect and Relationship of Frailty Indices on Survival After Transcatheter Aortic Valve Replacement.” JACC Cardiovasc Interv 13(2): 219-231.

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OBJECTIVES: This study sought to evaluate the ability of individual markers of frailty to predict outcomes after transcatheter aortic valve replacement (TAVR) and of their discriminatory value in different age groups. BACKGROUND: Appropriate patient selection for TAVR remains a dilemma, especially among the most elderly and potentially frail. METHODS: The study evaluated patients >/=65 years of age in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry, linked to Centers for Medicare and Medicaid administrative claims data, receiving elective TAVR from November 2011 to June 2016 (n = 36,242). Indices of frailty included anemia, albumin level, and 5-m walk speed. We performed Cox proportional hazards regression for 30-day and 1-year mortality, adjusting for risk factors known to be predictive of 30-day mortality in the Transcatheter Valve Therapy registry, as well as survival analysis. RESULTS: These indices are independently associated with mortality at 30 days and 1 year and provide incremental value in risk stratification for mortality, with low albumin providing the largest value (hazard ratio: 1.52). Those with low albumin and slower walking speed had longer lengths of stay and higher rates of bleeding and readmission (p < 0.001). Those with anemia also had higher rates of bleeding, readmission, and subsequent myocardial infarction (p < 0.001). CONCLUSIONS: This represents the largest study to date of the role of frailty indices after TAVR, further facilitating robust modeling and adjusting for a large number of confounders. These simple indices are easily attainable, and clinically relevant markers of frailty that may meaningfully stratify patients at risk for mortality after TAVR.

Hamandi, M., W. H. Ryan, P. A. Grayburn, E. Huff, L. Mallari and M. J. Mack (2020). “Misclassification of Mitral Valve Disease and Rate of Surgical Repair in the STS Database.” Ann Thorac Surg Jan 18. [Epub ahead of print].

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BACKGROUND: Surgical repair of primary mitral regurgitation (MR) is considered an indicator of quality performance. Therefore, accurate data reporting is critical for quality assessment. During an institutional quality review, MR etiology could not be determined in 40% of operations in our Society of Thoracic Surgeons (STS) database entries and thus our true repair rate could not be reliably ascertained. Therefore, we reviewed all source documents and echocardiograms to assess our true disease etiology and repair rate. METHODS: Sourse records and echocardiograms of all operations performed in a single healthcare system for a one-year period were reviewed by an experienced MV surgeon, an echocardiographic core lab and a data manager. Disease etiology and operation were compared to data previously entered in the database by post hoc chart abstraction. RESULTS: 314 isolated MV operations were performed. MR was originally classified as primary- 163 (52%), secondary- 22 (7%), rheumatic- 37 (12%), endocarditis- 24 (8%), other- 33 (10%), and unknown- 35 (11%). Reported repair rate for primary MR was 142/163 (87.1%). After review, etiology was determined to be primary- 177 (56%), secondary-33 (11%), rheumatic- 61 (20%), endocarditis- 25 (8%), and others- 18 (5%) resulting in a change of classification in 99/314 (31.5%) patients and a true repair rate for primary MR of 165/177 (93.2%). CONCLUSIONS: Source document and imaging review of MV surgery revealed significant discordance with post hoc chart abstraction methods. A more detailed data entry methodology is necessary to accurately report the true disease etiology and repair rates for primary MR.

Arnold, S. V., P. Manandhar, S. Vemulapalli, A. Kosinski, N. D. Desai, J. E. Bavaria, J. D. Carroll, M. J. Mack, V. H. Thourani and D. J. Cohen (2020). “Impact of Short-Term Complications of TAVR on Longer-Term Outcomes: Results from the STS/ACC Transcatheter Valve Therapy Registry.” Eur Heart J Qual Care Clin Outcomes Jan 11. [Epub ahead of print].

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BACKGROUND: While complications of TAVR have decreased, they still occur commonly and may negatively impact both short- and long-term outcomes. We sought to examine the association of complications after TAVR with survival and health status in a real world cohort. METHODS AND RESULTS: Among 45,884 TAVR patients from 513 US sites who survived 30 days, 21.4% had at least one major complication (stroke, bleed, vascular complication, new pacemaker, acute kidney injury [AKI], moderate/severe paravalvular leak [PVL]). In multivariable models, stage 3 AKI (HR 3.43, 95% CI 2.64-4.45), stroke (HR 2.62, 95% CI 2.06-3.32), and bleeding (HR 1.83, 95% CI 1.55-2.16) were independently associated with significantly increased risk of early death (<3 months) with slight attenuation in these hazards between 3 and 12 months. Moderate/severe PVL (HR 1.37, 95% CI 1.21-1.55) and new pacemaker (HR 1.15, 95% CI 1.05-1.25) were associated with more modest risk of excess mortality that was consistent through 12 months. Among surviving patients, stroke (-6.1 points, 95% CI -8.4 to -3.7), moderate/severe PVL (-3.2 points, 95% CI -4.9 to -1.6), and new pacemaker (-2.3, 95% CI -3.2 to -1.5) were associated with less improvement in 1-year health status, as assessed by the Kansas City Cardiomyopathy Questionnaire. CONCLUSIONS: In this study of contemporary TAVR, we found that complications remain common within the first 30 days after TAVR and are associated with worse one-year survival and health status among survivors. These findings support continued efforts to reduce major complications of TAVR and may also help define quality of care.

Mack, M., K. Al-Azizi and M. J. Reardon (2019). “Ninety-Day Outcome Assessment After Transcatheter and Surgical Aortic Valve Replacement-Is the Juice Worth the Squeeze?” JAMA Cardiol Dec 18. [Epub ahead of print].

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Measurement of outcomes after surgery and transcatheter valve interventions have become standard for quality assessment, performance improvement, and comparative effectiveness reporting and research. Public reporting of procedural outcomes has also become required in some states and is increasingly performed nationally. Initially, hospital performance measurement of outcomes after cardiac surgical procedures were limited to in-hospital mortality and major morbidity rates, because the data were readily available, relatively complete, and not overly burdensome for sites to collect. However, it soon became apparent that capturing in-hospital mortality and complication rates alone was not truly reflective of procedural outcomes, with up to one-third of periprocedural mortality occurring after hospital discharge but before 30 days. Hence, professional society–based clinical registries changed the main outcome performance metric to operative mortality and included any death that occurred during the initial hospital stay, independent of time, and any death within 30 days, independent of location. This hospital performance metric more accurately reflected the true outcomes after surgery and minimized the possibility of gaming reporting, but it did add a considerable burden of data collection to hospitals. Thus, 30-day mortality and major morbidity rates have become the foundation of procedure risk models and are the basis for the Society for Thoracic Surgeons’ 3-star hospital rating of cardiac surgery performance.