Michael J. Mack M.D.

Tanguturi, V. K., B. R. Lindman, P. Pibarot, J. J. Passeri, S. Kapadia, M. J. Mack, I. Inglessis, N. B. Langer, T. M. Sundt, J. Hung and S. Elmariah (2020). “Managing Severe Aortic Stenosis in the COVID-19 Era.” JACC Cardiovasc Interv Jun 1;S1936-8798(20)31265-6. [Epub ahead of print].

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The novel coronavirus-19 (COVID-19) pandemic has created uncertainty in the management of patients with severe aortic stenosis (AS). This population experiences high mortality from delays in treatment of valve disease but is largely overlapping with the population of highest mortality from COVID-19. We present strategies for managing patients with severe AS in the COVID-era. We suggest transitions to virtual assessments and consultation, careful pruning and planning of necessary testing, as well as fewer and shorter hospital admissions. These strategies center on minimizing patient exposure to COVID-19 and expenditure of human and health-care resources without significant sacrifice to patient outcomes during this public health emergency. Areas of innovation to improve our care during this time include increased use of wearable and remote devices to assess patient performance and vital signs, devices for facile cardiac assessment, and widespread use of clinical protocols for expedient discharge with virtual physical therapy and cardiac rehabilitation options.

Holmes, D. R., Jr., M. J. Mack, M. Alkhouli and S. Vemulapalli (2020). “Racial disparities and democratization of health care: A focus on TAVR in the United States.” Am Heart J 224: 166-170.

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What can be said with certainty is that there are real and documented disparities in care involving TAVR in the increasing population of patients with aortic stenosis.1–8,28–32These disparities may become more prominent as TAVR becomes the standard of care. There are multiple issues relating to this disparity including socioeconomic,genetic, personal valuations and expectations, access to care, and follow-up. Approaches to resolution need to take into consideration of these multiple issues from many angles and include multiple stakeholders – hospital systems to promote culturally competent team based care, reimbursement agencies, patient education, family support systems access to community based educational programs, industry resources working to develop trials with specific focus and recruitment goals to include racialand ethnic groups, and social services.29-32The CMS Accountable Health Communities Model project has been implemented and could potentially be used by the centers involved to focus on one limb of unmet needs. [No abstract; excerpt from article p.169-170].

Erhun, F., R. S. Kaplan, V. G. Narayanan, K. Brayton, M. Kalani, M. C. Mazza, C. Nguyen, T. Platchek, B. Mistry, R. Mann, D. Kazi, C. Pinnock, K. A. Schulman, J. Xue, D. Ballard, M. Mack, B. James, G. Poulsen, J. Punnen, D. Shetty and A. Milstein (2020). “Are cost advantages from a modern Indian hospital transferable to the United States?” Am Heart J 224: 148-155.

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BACKGROUND: Multiple modern Indian hospitals operate at very low cost while meeting US-equivalent quality accreditation standards. Though US hospitals face intensifying pressure to lower their cost, including proposals to extend Medicare payment rates to all admissions, the transferability of Indian hospitals’ cost advantages to US peers remains unclear. METHODS: Using time-driven activity-based costing methods, we estimate the average cost of personnel and space for an elective coronary artery bypass graft (CABG) surgery at two American hospitals and one Indian hospital (NH). All three hospitals are Joint Commission accredited and have reputations for use of modern performance management methods. Our case study applies several analytic steps to distinguish transferable from non-transferable sources of NH’s cost savings. RESULTS: After removing non-transferable sources of efficiency, NH’s residual cost advantage primarily rests on shifting tasks to less-credentialed and/or less-experienced personnel who are supervised by highly-skilled personnel when perceived risk of complications is low. NH’s high annual CABG volume facilitates such supervised work “downshifting.” The study is subject to limitations inherent in case studies, does not account for the younger age of NH’s patients, or capture savings attributable to NH’s negligible frequency of re-admission or post-acute care facility placement. CONCLUSIONS: Most transferable bases for a modern Indian hospital’s cost advantage would require more flexible American states’ hospital and health professional licensing regulations, greater family participation in inpatient care, and stronger support by hospital executives and clinicians for substantially lowering the cost of care via regionalization of complex surgeries and weekend use of costly operating rooms.

Pibarot, P., E. Salaun, A. Dahou, E. Avenatti, E. Guzzetti, M. S. Annabi, O. Toubal, M. Bernier, J. Beaudoin, G. Ong, J. Ternacle, L. Krapf, V. H. Thourani, R. Makkar, S. K. Kodali, M. Russo, S. R. Kapadia, S. C. Malaisrie, D. J. Cohen, J. Leipsic, P. Blanke, M. R. Williams, J. M. McCabe, D. L. Brown, V. Babaliaros, S. Goldman, W. Y. Szeto, P. Genereux, A. Pershad, M. C. Alu, K. Xu, E. Rogers, J. G. Webb, C. R. Smith, M. J. Mack, M. B. Leon and R. T. Hahn (2020). “Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial.” Circulation Apr 10. [Epub ahead of print].

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Background: The objective of this study is to compare echocardiographic findings in low risk patients with severe aortic stenosis (AS) following surgical (SAVR) or transcatheter aortic valve replacement (TAVR). Methods: The Placement of Aortic Transcatheter Valves 3 (PARTNER 3) trial randomized 1000 patients with severe AS and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline, and at 30 days and 1 year post-procedure were analyzed by a consortium of 2 echocardiography core laboratories. Results: The percentage of moderate/severe aortic regurgitation (AR) was low and not statistically different between TAVR vs. SAVR groups (30 days: 0.8% vs. 0.2%; p=0.38). However, mild AR was more frequent following TAVR vs. SAVR (30 days: 28.8% vs. 4.2 %; p<0.001). At 1 year, mean transvalvular gradient (13.7+/-5.6 vs. 11.6+/-5.0 mmHg; p=0.12) and aortic valve area (1.72+/-0.37 vs. 1.76+/-0.42 cm(2); p=0.12) were similar in TAVR vs. SAVR. The percentage of severe prosthesis-patient mismatch (PPM) at 30 days was low and similar between TAVR and SAVR (4.6 vs. 6.3%, p=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR vs. SAVR at 1 year (3.7+/-0.8 vs. 3.9+/-0.9 mmHg/mL/m(2) ; p<0.001). Tricuspid annulus plane systolic excursion (TAPSE) decreased and the percentage of moderate/severe tricuspid regurgitation increased from baseline to 1 year in SAVR, whereas remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low TAPSE, but not moderate/severe AR or severe PPM, were associated with increased risk of the composite endpoint of mortality, stroke and re-hospitalization at 1 year. Conclusions: In patients with severe AS and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate/severe AR compared with SAVR, but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe PPM, and LV mass regression were similar in TAVR versus SAVR. SAVR was associated with significant deterioration of RV systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low TAPSE were associated with worse outcome at 1 year whereas AR or severe PPM were not.

Mack, M. (2020). “Commentary: Bundled payment models in value-based care: A toe in the (Colombian) water!” J Thorac Cardiovasc Surg 159(5): 1931-1932.

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Value in healthcare delivery is increased by improving quality, decreasing cost, or, optimally, both. Alternative payment models in which all costs associated with a procedure are “bundled,” with a focus on decreasing the variability of care, has demonstrated some success. (Excerpt from text; no abstract available.)