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. (2016). “2016 annual report of the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry.” J Am Coll Cardiol: 2016 Dec [Epub ahead of print].

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BACKGROUND: The STS/ACC Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration (FDA) approved transcatheter valve devices performed in the United States and is mandated as a condition of reimbursement by a Centers for Medicaid and Medicare Services (CMS) 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: Data for all patients receiving commercially approved devices from 2012 through December 31, 2015 are entered in the TVT Registry. RESULTS: The 54,782 TAVR patients demonstrated decreases in expected risk of 30-day operative mortality (STS PROM) 7% to 6% and TAVR PROM (TVT PROM) 4% to 3% (both p<.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9% and one-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 TMC in 2015 were similar to 2013-14 patients with hospital mortality of 2% with mitral regurgitation reduced to gradient /= 2 in 87% of patients (p<.0001). The 349 patients who underwent MViV and MViR procedures were high risk with, an STS PROM for MVR of 11%. The observed hospital mortality was 7.2% and 30-day post procedure was 8.5%. SUMMARY: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies. CONDENSED ABSTRACT: The STS/ACC TVT Registry captures all Food and Drug Administration (FDA) approved transcatheter valve devices preformed in the United States and is mandated as a condition for reimbursement by the Centers for Medicare Services. TAVR patients' expected risks of mortality and actual in-hospital mortality decreased. Transcatheter mitral clip procedures had a low mortality with reduced in mitral regurgitation to grade /= 2 in 87%. Mitral valve in valve or valve in ring patients were high risk for mortality, but actual hospital mortality was lower. The TVT Registry is an innovative registry that monitors quality, safety and trends of these evolving technologies.

Arsalan, M., G. Filardo, W. K. Kim, J. J. Squiers, B. Pollock, C. Liebetrau, J. Blumenstein, J. Kempfert, A. Van Linden, A. Arsalan-Werner, C. Hamm, M. J. Mack, H. Moellmann and T. Walther (2016). “Prognostic value of body mass index and body surface area on clinical outcomes after transcatheter aortic valve implantation.” Clin Res Cardiol 105(12): 1042-1048.

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BACKGROUND: Inverse associations between Body Mass Index (BMI) and Body Surface Area (BSA) with mortality in patients after Transcatheter Aortic Valve Implantation (TAVI) have been reported. This “obesity paradox” is controversial, and it remains unclear which parameter, BMI or BSA, is of greater prognostic value. The aim of this study was to investigate the association of BMI and BSA on short- and mid-term outcomes after TAVI. METHODS AND RESULTS: This prospective, observational study consisted of 917 consecutive patients undergoing TAVI at our center from 2011 to 2014. The association between BMI/BSA and mortality (at 30 days and 1 year) was assessed using restricted cubic spline functions in propensity-adjusted (by Society of Thoracic Surgeons (STS) risk factors) logistic and Cox proportional models, respectively. The median age of the patients was 82.6 years, with a mean STS Predicted Risk of Mortality (STS-PROM) of 6.6 +/- 4.3 %. Throughout the study period (mean follow-up time was 297 days), 150 (16.4 %) patients died; 72 (7.9 %) patients died within 30 days of TAVI. After risk adjustment, the association between body constitution and 30-day mortality was not significant for either measure (BMI p = 0.25; BSA p = 0.32). However, BMI (p = 0.01), but not BSA (p = 0.13), was significantly associated with 1-year survival. There was no association between stroke, vascular complications, or length of stay with BMI or BSA. CONCLUSIONS: BMI was associated with survival at 1-year after TAVI. Despite the trend towards implementing BSA in risk score calculation, BMI may be more suitable for the assessment of TAVI patients.

Sannino, A., R. C. Stoler, B. Lima, M. Szerlip, A. C. Henry, R. Vallabhan, R. C. Kowal, D. L. Brown, M. J. Mack and P. A. Grayburn (2016). “Frequency of and prognostic significance of atrial fibrillation in patients undergoing transcatheter aortic valve implantation.” Am J Cardiol 118(10): 1527-1532.

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The prognostic implications of preexisting atrial fibrillation (AF) and new-onset AF (NOAF) in transcatheter aortic valve implantation (TAVI) remain uncertain. This study assesses the epidemiology of AF in patients treated with TAVI and evaluates their outcomes according to the presence of preexisting AF or NOAF. A retrospective analysis of 708 patients undergoing TAVI from 2 heart hospitals was performed. Patients were divided into 3 study groups: sinus rhythm (n = 423), preexisting AF (n = 219), and NOAF (n = 66). Primary outcomes of interest were all-cause death and stroke both at 30-day and at 1-year follow-up. Preexisting AF was present in 30.9% of our study population, whereas NOAF was observed in 9.3% of patients after TAVI. AF and NOAF patients showed a higher rate of 1-year all-cause mortality compared with patients in sinus rhythm (14.6% vs 6.5% for preexisting AF and 16.3% vs 6.5% for NOAF, p = 0.007). No differences in 30-day mortality were observed between groups. In patients with AF (either preexisting and new-onset), those discharged with single antiplatelet therapy displayed higher mortality rates at 1 year (42.9% vs 11.7%, p = 0.006). Preexisting AF remained an independent predictor of mortality at 1-year follow-up (hazard ratio [HR] 2.34, 95% CI 1.22 to 4.48, p = 0.010). Independent predictors of NOAF were transapical and transaortic approach as well as balloon postdilatation (HR 3.48, 95% CI 1.66 to 7.29, p = 0.001; HR 5.08, 95% CI 2.08 to 12.39, p <0.001; HR 2.76, 95% CI 1.25 to 6.08, p = 0.012, respectively). In conclusion, preexisting AF is common in patients undergoing TAVI and is associated with a twofold increased risk of 1-year mortality. This negative effect is most pronounced in patients discharged with single antiplatelet therapy compared with other antithrombotic regimens.

Capoulade, R., X. Zeng, J. R. Overbey, G. Ailawadi, J. H. Alexander, D. Ascheim, M. Bowdish, A. C. Gelijns, P. Grayburn, I. L. Kron, R. A. Levine, M. J. Mack, S. Melnitchouk, R. E. Michler, J. C. Mullen, P. O’Gara, M. K. Parides, P. Smith, P. Voisine and J. Hung (2016). “Impact of left ventricular to mitral valve ring mismatch on recurrent ischemic mitral regurgitation after ring annuloplasty.” Circulation 134(17): 1247-1256.

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BACKGROUND: In ischemic mitral regurgitation (IMR), ring annuloplasty is associated with a significant rate of recurrent MR. Ring size is based on intertrigonal distance without consideration of left ventricular (LV) size. However, LV size is an important determinant of mitral valve (MV) leaflet tethering before and after repair. We aimed to determine whether LV-MV ring mismatch (mismatch of LV size relative to ring size) is associated with recurrent MR in patients with IMR after restrictive ring annuloplasty. METHODS: Patients with moderate or severe IMR from the 2 Cardiothoracic Surgical Trials Network IMR trials who received MV repair were examined at 1 year after surgery. Baseline LV size was assessed by LV end-diastolic dimension and LV end-systolic dimension (LVESd). LV-MV ring mismatch was calculated as the ratio of LV to ring size (LV end-diastolic dimension/ring size and LVESd/ring size). RESULTS: At 1 year after ring annuloplasty, 45 of 214 patients with MV repair (21%) had moderate or greater MR. In univariable logistic regression analysis, larger LVESd (P=0.02) and LVESd/ring size (P=0.007) were associated with recurrent MR. In multivariable models adjusted for age, sex, baseline LV ejection fraction, and severe IMR, only LVESd/ring size (odd ratio per 0.5 increase, 2.20; 95% confidence interval, 1.05-4.62; P=0.038) remained significantly associated with 1-year MR recurrence. CONCLUSIONS: LV-MV ring size mismatch is associated with increased risk of MR recurrence. This finding may be helpful in guiding choice of ring size to prevent recurrent MR in patients undergoing MV repair and in identifying patients who may benefit from MV repair with additional subvalvular intervention or MV replacement rather than repair alone.

Kurlansky, P., M. Herbert, S. Prince and M. Mack (2016). “Coronary artery bypass graft versus percutaneous coronary intervention: Meds matter: Impact of adherence to medical therapy on comparative outcomes.” Circulation 134(17): 1238-1246.

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BACKGROUND: Multiple studies have compared coronary artery bypass graft (CABG) with percutaneous coronary interventions (PCI) for coronary revascularization. There is considerable evidence that adherence to medical therapy can affect the outcomes of therapeutic interventions. However, the long-term influence of compliance with recommended medical therapy on the comparative outcomes of CABG versus PCI remains to be defined. METHODS: All non-ST-segment-elevation myocardial infarction patients undergoing coronary revascularization in an 8-hospital network were followed for up to 8 years to determine medication history and major adverse cardiac events: all-cause mortality, nonfatal myocardial infarction, and reintervention. All mortalities were checked against the Social Security Death Index. Survival curves were derived with Kaplan-Meier methods; hazard ratios were calculated with the Cox proportional hazard model; and propensity score matching was used to account for differences in patient selection. RESULTS: Among the 973 CABG and 2255 PCI patients, Kaplan-Meier major adverse cardiac event-free survival curves demonstrated a significant benefit for antiplatelet, lipid-lowering, and beta-blocker therapy in both the CABG and PCI groups (P=0.001 for all 3 medications). Cox regression identified compliance with optimal medical therapy as a more powerful predictor of major adverse cardiac event-free survival than choice of therapy (hazard ratio for noncompliance=2.79; 95% confidence limits, 2.19-3.54; P<0.001; hazard ratio for PCI versus CABG=1.68, 95% confidence limits, 138-2.04; P<0.001). In propensity-matched patients, CABG outcomes were superior to PCI outcomes in patients nonadherent to optimal medical therapy (P=0.001) but were not different in patients adherent to optimal medical therapy (P=0.574). CONCLUSIONS: Regardless of coronary revascularization strategy, medication adherence has a dramatic effect on long-term outcome. Among comparable patients who adhere to optimal medical therapy, outcomes of PCI and CABG may not differ; however, among nonadherent patients, CABG affords better major adverse cardiac event-free survival. Therefore, patient compliance with medical therapy may inform clinical decision making and should be incorporated into all future comparative studies of comparative coronary revascularization strategies.