Michael J. Mack M.D.

Davierwala, P. M., C. Gao, D. Thuijs, R. Wang, H. Hara, M. Ono, T. Noack, S. Garg, N. O’Leary, M. Milojevic, A. P. Kappetein, M. C. Morice, M. J. Mack, R. J. van Geuns, D. R. Holmes, M. Gaudino, D. P. Taggart, Y. Onuma, F. W. Mohr and P. W. Serruys (2021). “Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease.” Eur Heart J Aug 18;ehab537. [Epub ahead of print].

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AIM: The aim of this study was to compare long-term all-cause mortality between patients receiving percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using multiple (MAG) or single arterial grafting (SAG). METHODS AND RESULTS: The current study is a post hoc analysis of the SYNTAX Extended Survival Study, which compared PCI with CABG in patients with three-vessel (3VD) and/or left main coronary artery disease (LMCAD) and evaluated survival with ≥10 years of follow-up. The primary endpoint was all-cause mortality at maximum follow-up (median 11.9 years) assessed in the as-treated population. Of the 1743 patients, 901 (51.7%) underwent PCI, 532 (30.5%) received SAG, and 310 (17.8%) had MAG. At maximum follow-up, all-cause death occurred in 305 (33.9%), 175 (32.9%), and 70 (22.6%) patients in the PCI, SAG, and MAG groups, respectively (P < 0.001). Multiple arterial grafting [adjusted hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.49-0.89], but not SAG (adjusted HR 0.83, 95% CI 0.67-1.03), was associated with significantly lower all-cause mortality compared with PCI. In patients with 3VD, both MAG (adjusted HR 0.55, 95% CI 0.37-0.81) and SAG (adjusted HR 0.68, 95% CI 0.50-0.91) were associated with significantly lower mortality than PCI, whereas in LMCAD patients, no significant differences between PCI and MAG (adjusted HR 0.90, 95% CI 0.56-1.46) or SAG (adjusted HR 1.11, 95% CI 0.81-1.53) were observed. In patients with revascularization of all three major myocardial territories, a positive correlation was observed between the number of myocardial territories receiving arterial grafts and survival (Ptrend = 0.003). CONCLUSION: Our findings suggest that MAG might be the more desirable configuration for CABG to achieve lower long-term all-cause mortality than PCI in patients with 3VD and/or LMCAD. TRIAL REGISTRATION: Registered on clinicaltrial.gov. SYNTAXES: NCT03417050

Arnold, S. V., G. W. Stone, S. S. Jain, M. J. Mack, J. T. Saxon, Z. Zhang, J. Lindenfeld, W. T. Abraham and D. J. Cohen (2021). “Prognostic Importance of Health Status Versus Functional Status in Heart Failure and Secondary Mitral Regurgitation.” JACC Heart Fail 9(9): 684-692.

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OBJECTIVES: This study sought to understand the extent to which health status and exercise capacity are independently associated with long-term outcomes in patients with heart failure (HF) and secondary mitral regurgitation (MR). BACKGROUND: Secondary MR in patients with HF leads to impaired health status (Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS]) and exercise capacity (6-minute walk distance [6MWD]), both of which improve after transcatheter mitral valve repair (TMVr). METHODS: The study used data from the COAPT trial (N = 604) to examine the association of baseline KCCQ-OS and 6MWD with 2-year mortality and HF hospitalization, adjusting for treatment arm and patient factors. We also examined the association of change in KCCQ-OS and 6MWD from baseline to 1 month with risk of outcomes from 1 month to 2 years. Interactions of KCCQ-OS and 6MWD with treatment assignment were explored. RESULTS: Mean baseline KCCQ-OS was 53 ± 23 points, and 6MWD was 240 ± 125 meters. In models including both measures, greater baseline 6MWD (but not KCCQ-OS) was associated with reduced 2-year mortality (HR per 125 meters: 0.75, 95% CI: 0.61-0.92). When stratified by treatment group, both baseline KCCQ-OS and 6MWD were independently associated with HF hospitalization in patients treated with medical therapy, whereas only KCCQ-OS was associated with HF hospitalization in patients treated with TMVr. In separate analyses, 1-month improvements in KCCQ-OS and 6MWD were each associated with lower subsequent risk of mortality and HF hospitalization, independent of treatment group. CONCLUSIONS: Among patients with HF and severe secondary MR, assessment of both health status and exercise capacity provide complementary prognostic information for patients with HF and severe secondary MR-both before and after TMVr. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079).

Ternacle, J., Al-Azizi, K., Szerlip, M., Potluri, S., Hamandi, M., Blanke, P., Leipsic, J., Dahou, A., Salaun, E., Vincent, F., Rogers, E., Alu, M.C., Lu, M., Yu, X., Thourani, V.H., Hahn, R.T., Leon, M.B., Pibarot, P. and Mack, M.J. (2021). “Impact of Predilation During Transcatheter Aortic Valve Replacement: Insights From the PARTNER 3 Trial.” Circ Cardiovasc Interv Jun 18;CIRCINTERVENTIONS120010336. [Epub ahead of print]. Circinterventions120010336.

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BACKGROUND: The use of predilation during transcatheter aortic valve replacement (TAVR) is variable, and its association with outcomes remains unknown. We evaluated the impact of predilation versus no predilation (direct TAVR) in the low-risk population enrolled in the PARTNER 3 trial (Placement of Aortic Transcatheter Valves). METHODS: In the PARTNER 3 trial, 495 patients with severe symptomatic aortic stenosis underwent TAVR with the SAPIEN 3 valve. The use of predilation was left to operator discretion. The primary end point was a composite of all-cause death, stroke, or rehospitalization. Secondary end points included valve hemodynamic performance and the need for postdilation. Propensity score matching was performed. RESULTS: Predilation and direct TAVR were performed in 286 (57.8%) and 209 (42.2%) patients, respectively. Before matching, the primary end point occurrence at 30 days (3.8% versus 4.8%, P=0.604) and 1 year (8.7% versus 8.1%, P=0.831) was similar in the predilation versus direct TAVR groups. Similar results were observed after matching (202 patients in each groups). Incidence of ≥ mild paravalvular regurgitation was similar in both groups. Incidence of severe prosthesis-patient mismatch was low but higher in the predilation group versus the direct TAVR group (8.2% versus 2.6%, P=0.023). Compared with direct TAVR, the use of predilation was associated with longer procedure duration (63.2 versus 51.4 minutes, P=0.001), while the rate of postdilation did not differ between the 2 groups (24.8% versus 18.8%, P=0.150). CONCLUSIONS: Predilation and direct TAVR are safe in patients with low surgical risk and favorable aortic valve anatomy. Direct TAVR decreased the procedure duration and did not predispose to more postdilation.

Hahn, R.T., Douglas, P.S., Jaber, W.A., Leipsic, J., Kapadia, S., Thourani, V.H., Makkar, R., Kodali, S., Clavel, M.A., Khalique, O.K., Weissman, N.J., Blanke, P., Chen, Y., Smith, C.R., Mack, M.J., Leon, M.B. and Pibarot, P. (2021). “Doppler Velocity Index Outcomes Following Surgical or Transcatheter Aortic Valve Replacement in the PARTNER Trials.” JACC Cardiovasc Interv Jun 23;S1936-8798(21)00682-8. [Epub ahead of print].

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OBJECTIVES: The aim of this study was to assess the association between Doppler velocity index (DVI) and 2-year outcomes for balloon-expandable SAPIEN 3 transcatheter aortic valve replacement (TAVR) and for surgical aortic valve replacement (SAVR). BACKGROUND: DVI >0.35 is normal for a prosthetic valve, but recent studies suggest that DVI <0.50 is associated with poor outcomes following TAVR. METHODS: Patients with severe aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valve) 2 (intermediate surgical risk) or PARTNER 3 (low surgical risk) trial undergoing TAVR (n = 1,450) or SAVR (n = 1,303) were included. Patients were divided into 3 DVI groups on the basis of core laboratory-assessed discharge or 30-day echocardiograms: DVI(LOW) (≤0.35), DVI(INTERMEDIATE) (>0.35 to ≤0.50), and DVI(HIGH) (>0.50). Two-year outcomes were assessed. RESULTS: Following TAVR, there were no differences among the 3 DVI groups in composite outcomes of death, stroke, or rehospitalization or in any individual components of 2-year outcomes (P > 0.70 for all). Following SAVR, there was no difference among DVI groups in the composite outcome (P = 0.27), but there was a significant association with rehospitalization (P = 0.02). Restricted cubic-spline analysis for combined outcomes showed an increased risk with post-SAVR DVI ≤0.35 but no relationship post-TAVR. DVI ≤0.35 was associated with increased 2-year composite outcome for SAVR (HR: 1.81; 95% CI: 1.29-2.54; P < 0.001), with no adverse outcomes for TAVR (P = 0.86). CONCLUSIONS: In intermediate- and low-risk cohorts of the PARTNER trials, DVI ≤0.35 predicted worse 2-year outcomes following SAVR, driven primarily by rehospitalization, with no adverse outcomes associated with DVI following TAVR with the balloon-expandable SAPIEN 3 valve.

Ono, M., Serruys, P.W., Hara, H., Kawashima, H., Gao, C., Wang, R., Takahashi, K., O’Leary, N., Wykrzykowska, J.J., Sharif, F., Piek, J.J., Garg, S., Mack, M.J., Holmes, D.R., Morice, M.C., Head, S.J., Kappetein, A.P., Thuijs, D., Noack, T., Davierwala, P.M., Mohr, F.W., Cohen, D.J. and Onuma, Y. (2021). “10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease.” J Am Coll Cardiol 77(22): 2761-2773.

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BACKGROUND: The optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear. OBJECTIVES: The goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD). METHODS: In the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models. RESULTS: Among 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; p(interaction) = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; p(interaction) = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: -0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients. CONCLUSIONS: Elderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode.