Michael J. Mack M.D.

Kaneko, T., Vemulapalli, S., Kohsaka, S., Shimamura, K., Stebbins, A., Kumamaru, H., Nelson, A. J., Kosinski, A., Maeda, K., Bavaria, J. E., Saito, S., Reardon, M. J., Kuratani, T., Popma, J. J., Inohara, T., Thourani, V. H., Carroll, J. D., Shimizu, H., Takayama, M., Leon, M. B., Mack, M. J. and Sawa, Y. (2022). “Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J-TVT.” J Am Heart Assoc: e023848.

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Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; P<0.001), were more frequently women (45.9% versus 68.1%; P<0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P<0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; P<0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P<0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P<0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.

Mentias, A., Keshvani, N., Desai, M. Y., Kumbhani, D. J., Sarrazin, M. V., Gao, Y., Kapadia, S., Peterson, E. D., Mack, M., Girotra, S. and Pandey, A. (2022). “Risk-Adjusted, 30-Day Home Time After Transcatheter Aortic Valve Replacement as a Hospital-Level Performance Metric.” J Am Coll Cardiol 79(2): 132-144.

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BACKGROUND: Patient-centric measures of hospital performance for transcatheter aortic valve replacement (TAVR) are needed. OBJECTIVES: This study evaluated 30-day, risk-adjusted home time as a hospital performance metric for patients who underwent TAVR. METHODS: This study identified 160,792 Medicare beneficiaries who underwent elective TAVR from 2015 to 2019. Home time was calculated for each patient as the number of days alive and spent outside the hospital, skilled nursing facility (SNF), and long-term acute care facility for 30 days after the TAVR procedure date. Correlations between risk-adjusted, 30-day home time and other metrics (30-day, risk-adjusted readmission rate [RSRR], 30-day, risk-adjusted mortality rate [RSMR], and annual TAVR volume) were estimated using Pearson’s correlation. Meaningful upward or downward reclassification (≥2 quartile ranks) in hospital performance based on quartiles of risk-adjusted, 30-day home time compared with quartiles of other measures were assessed. RESULTS: Median risk-adjusted, 30-day home time was 27.4 days (interquartile range [IQR]: 26.3-28.5 days). The largest proportion of days lost from 30-day home time was hospital stay after TAVR and SNF stay. An inverse correlation was observed between hospital-level, risk-adjusted, 30-day home time and 30-day RSRR (r = -0.465; P < 0.001) and 30-day RSMR (r = -0.3996; P < 0.001). The use of the 30-day, risk-adjusted home time was associated with reclassification in hospital performance rank hospitals compared with other metrics (9.1% up-classified, 11.2% down-classified vs RSRR; 9.1% up-classified, 10.3% down-classified vs RSMR; and 20.1% up-classified, 19.3% down-classified vs annual TAVR volume). CONCLUSIONS: Risk-adjusted, 30-day home time represents a novel patient-centered performance metric for TAVR hospitals that may provide a complimentary assessment to currently used metrics.

Mack, M. J., Leon, M. B., Wu, C. and Zuckerman, B. (2022). “The Heart Valve Collaboratory: A Disruptive Model in the Management of Valvular Heart Disease.” J Am Coll Cardiol 79(2): 192-196

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The last decade has seen significant achievements in the field of valvular heart disease as transcatheter technologies have been introduced. Despite these advances in scientific, translational, and clinical research, the important stakeholders, including investigators, innovators, medical device manufacturers, payers, and regulators, have become increasingly aware of the limitations in the current valvular heart disease research ecosystem. The perpetuation of specialty silos, lack of adoption of more efficient clinical research models, decreased therapy access to underserved and under-represented populations, and disjointed multistakeholder efforts to address common challenges and systemic issues have become impediments to progress. To directly address these fundamental limitations, a new “collaboratory” model was developed.

Vincent, F., Thourani, V. H., Ternacle, J., Redfors, B., Cohen, D. J., Hahn, R. T., Li, D., Crowley, A., Webb, J. G., Mack, M. J., Kapadia, S., Russo, M., Smith, C. R., Alu, M. C., Leon, M. B. and Pibarot, P. (2022). “Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials.” Circ Cardiovasc Qual Outcomes 15(1): e007948.

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BACKGROUND: Circadian rhythms may influence myocardial tolerance to ischemia-reperfusion phenomena occurring during cardiac procedures. While conflicting results exist on the effect of time-of-day on surgical aortic valve replacement (SAVR), afternoon procedures could be associated with a reduced risk of death, rehospitalization or periprocedural myocardial infarction, compared with morning procedures. We examined the impact of procedure time-of-day on outcomes after transcatheter aortic valve replacement (TAVR) or SAVR. METHODS: We analyzed patients at intermediate- or high-surgical risk who underwent elective TAVR (n=4457) or SAVR (n=1129) in the PARTNER (Placement of Aortic Transcatheter Valve) 1 and 2 trials and registries according to time-of-day (morning versus afternoon) using the Kaplan-Meier event rates and multivariable Cox proportional hazards regression models. Sensitivity analysis was conducted using 1:1 propensity-score matching. The primary end point was all-cause death or rehospitalization at 2 years. RESULTS: At 2 years, no difference was observed between patients operated in the morning versus the afternoon within the SAVR (32.3% versus 30.6%, adjusted hazard ratio, 1.08 [95% CI, 0.82-1.41], P=0.58) and TAVR cohorts (35.7% versus 35.4%, adjusted hazard ratio, 1.01 [95% CI, 0.89-1.14], P=0.86) with regards to the primary end point. Rates of periprocedural myocardial infarction were low and similar between morning and afternoon in SAVR (1.6% versus 1.0%, P=0.51) and TAVR (0.4% versus 0.4%, P=0.86), as were all other clinical end points. Similar results were observed in propensity-score matched analysis. CONCLUSIONS: Procedure time-of-day was not associated with clinical outcomes after TAVR or SAVR. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00530894, NCT01314313, NCT03222141, and NCT03222128.

Dietz, M. F., van Wijngaarden, A. L., Mack, M. J., Braun, J., Ajmone Marsan, N., Delgado, V., Klautz, R. and Bax, J. J. (2022). “Long-Term Impact of Preventive Tricuspid Valve Annuloplasty on Right Ventricular Remodeling.” Am J Cardiol.

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In patients with primary mitral regurgitation (MR), concomitant tricuspid valve (TV) annuloplasty at the time of left-sided valve surgery is indicated in case of a dilated TV annulus ≥40 mm independent of the presence or severity of tricuspid regurgitation (TR). However, the long-term impact on right ventricular (RV) adverse remodeling is less well established and the benefit of preventive TV annuloplasty remains controversial. The aim of the study was to assess differences in long-term RV adverse remodeling and the development of significant TR in those patients. In total, 98 patients (mean age 65 ± 11 years, 85% men) with significant primary MR and TV annulus dilatation ≥40 mm without significant TR who underwent mitral valve (MV) repair with or without concomitant TV annuloplasty were included. Of the 98 patients, 28 patients underwent isolated MV repair without TV annuloplasty and 70 patients received concomitant TV annuloplasty at the time of MV surgery. The RV basal diameter (p = 0.03), RV long-axis diameter (p = 0.04), RV end-diastolic area (p <0.01), and RV end-systolic area (p = 0.03) showed less adverse remodeling at follow-up in patients with concomitant TV annuloplasty compared with patients without TV annuloplasty. Additionally, 4 patients (14%) in the subgroup without TV annuloplasty developed significant TR during follow-up in contrast to zero patients in the subgroup with TV annuloplasty (p = 0.001). In conclusion, concomitant preventive TV annuloplasty during MV surgery in patients with primary MR, no significant TR and a tricuspid annulus (≥40 mm) prevented RV adverse remodeling and the development of significant TR at long-term follow-up.