Michael J. Mack M.D.

Basra, S. S., A. Gopal, K. R. Hebeler, H. Baumgarten, A. Anderson, S. P. Potluri, W. T. Brinkman, M. Szerlip, D. Gopal, G. Filardo, J. M. DiMaio, D. L. Brown, P. A. Grayburn, M. J. Mack and E. M. Holper (2018). “Clinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Aortic Valves by 4DCT.” Ann Thorac Surg. Aug 25. [Epub ahead of print].

Full text of this article.

BACKGROUND: The incidence of leaflet thrombosis after transcatheter aortic valve replacement (TAVR) with active surveillance by 4- Dimensional Computed Tomography (4DCT) ranges from 7% to 14%. The incidence of leaflet thrombosis when 4DCT is performed for clinical and echocardiographic indications is unknown. METHODS: All patients with prior TAVR or surgical aortic valve replacement (SAVR) that underwent evaluation between 10/2015 – 1/2017 at our institution and had clinical or echocardiographic indications of leaflet thrombosis were evaluated by 4DCT. Indications for 4DCT included: A) Echocardiographic: 1) Interval increase in mean gradient >/=10 mmHg; 2) Interval decrease in ejection fraction (>/=10 percent) 3) Thrombus seen on TTE 4) Persistent or increasing paravalvular leak 4) Valve dehiscence or thickened leaflets seen on TTE; B) Clinical: 1) Stroke 2) TIA 3) New/worsening heart failure RESULTS: 612 patients underwent TAVR during the study period. 101 patients (55 TAVR; 46 SAVR) met the criteria for 4DCT imaging. Leaflet thrombosis was seen in 17/55 (30.9%) TAVR and 15/46 (32.6%) SAVR patients. Follow-up imaging with 4DCT after treatment with anticoagulation showed improvement/resolution in thrombus burden and leaflet excursion in all TAVR and 2/3rd SAVR patients. CONCLUSIONS: In patients with clinical or echocardiographic indications suggestive of leaflet thrombosis, 1/3rd of patients were found to have evidence of leaflet thrombosis using 4DCT. This allowed tailored anticoagulation therapy with resolution of the thrombus in most patients avoiding unnecessary anticoagulation in the remaining 2/3rds of patients.

Tang, G. H. L., S. Zaid, I. George, O. K. Khalique, Y. Abramowitz, Y. Maeno, R. R. Makkar, H. Jilaihawi, N. Kamioka, V. H. Thourani, V. Babaliaros, J. G. Webb, N. M. Htun, A. Attinger-Toller, H. Ahmad, R. Kaple, K. Sharma, J. A. Kozina, T. Kaneko, P. Shah, S. A. Hirji, N. D. Desai, S. Anwaruddin, D. Jagasia, H. C. Herrmann, S. S. Basra, M. A. Szerlip, M. J. Mack, M. Mathur, C. W. Tan, C. W. Don, R. Sharma, S. Gafoor, M. Zhang, S. R. Kapadia, S. L. Mick, A. Krishnaswamy, N. Amoroso, A. Salemi, S. C. Wong, A. S. Kini, J. Rodes-Cabau, M. B. Leon and S. K. Kodali (2018). “Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve.” JACC Cardiovasc Interv 11(14): 1377-1387.

Full text of this article.

OBJECTIVES: The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: The largest recommended annular area for the 29-mm S3 is 683 mm(2). However, experience with S3 TAVR in annuli >683 mm(2) has not been widely reported. METHODS: From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 +/- 38 mm(2) (range: 684 to 852 mm(2)) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium-2 outcomes were reported. RESULTS: Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 +/- 12.4% at the noncoronary cusp and 20.7 +/- 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity. CONCLUSIONS: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.

Tuzcu, E. M., S. R. Kapadia, S. Vemulapalli, J. D. Carroll, D. R. Holmes, Jr., M. J. Mack, V. H. Thourani, F. L. Grover, J. M. Brennan, R. M. Suri, D. Dai and L. G. Svensson (2018). “Transcatheter Aortic Valve Replacement of Failed Surgically Implanted Bioprostheses: The STS/ACC Registry.” J Am Coll Cardiol 72(4): 370-382.

Full text of this article.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been shown to be feasible, yet the safety and efficacy in relation to native valve (NV) TAVR are not known. OBJECTIVES: This study sought to evaluate the safety and effectiveness of ViV TAVR for failed surgical aortic valve replacement (SAVR) by comparing it with the benchmark of NV TAVR. METHODS: Patients who underwent ViV-TAVR (n = 1,150) were matched 1:2 (on sex, high or extreme risk, hostile chest or porcelain aorta, 5-m-walk time, and Society of Thoracic Surgeons Predicted Risk of Mortality for reoperation) to patients undergoing NV-TAVR (n = 2,259). Baseline characteristics, procedural data, and in-hospital outcomes were obtained from the Transcatheter Valve Therapy Registry. The 30-day and 1-year outcomes were obtained from linked Medicare administrative claims data. RESULTS: Unadjusted analysis revealed lower 30-day mortality (2.9% vs. 4.8%; p < 0.001), stroke (1.7% vs. 3.0%; p = 0.003), and heart failure hospitalizations (2.4% vs. 4.6%; p < 0.001) in the ViV-TAVR compared with NV-TAVR group. Adjusted analysis revealed lower 30-day mortality (hazard ratio: 0.503; 95% confidence interval: 0.302 to 0.839; p = 0.008), lower 1-year mortality (hazard ratio: 0.653; 95% confidence interval: 0.505 to 0.844; p = 0.001), and hospitalization for heart failure (hazard ratio: 0.685; 95% confidence interval: 0.500 to 0.939; p = 0.019) in the ViV-TAVR group. Patients in the ViV-TAVR group had higher post-TAVR mean gradient (16 vs. 9 mm Hg; p < 0.001), but less moderate or severe aortic regurgitation (3.5% vs. 6.6%; p < 0.001). Post-TAVR gradients were highest in small SAVRs and stenotic SAVRs. CONCLUSIONS: Comparison with the benchmark NV-TAVR shows ViV-TAVR to be a safe and effective procedure in patients with failed SAVR who are at high risk for repeat surgery.

Sherwood, M. W., S. Vemulapalli, J. K. Harrison, D. Dai, A. N. Vora, M. J. Mack, D. R. Holmes, J. S. Rumsfeld, D. J. Cohen, V. H. Thourani, A. Kirtane and E. D. Peterson (2018). “Variation in post-TAVR antiplatelet therapy utilization and associated outcomes: Insights from the STS/ACC TVT Registry.” Am Heart J 204: 9-16.

Full text of this article.

BACKGROUND: Dual antiplatelet therapy (DAPT) is recommended following transcatheter aortic valve replacement (TAVR); however, the optimal antiplatelet strategy is undefined, and little is known about practice patterns. We aimed to describe contemporary practice patterns of antiplatelet therapy and their relationship to outcomes post-TAVR. METHODS: The population was derived from the National Cardiovascular Data Registry, Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry with Center for Medical Services linkage for 1-year outcomes from October 1, 2011 to June 30,2016. The primary outcome measured was DAPT use in patients without anticoagulation. Secondary outcomes included death, major bleeding, myocardial infarction (MI), and stroke at 1year. RESULTS: Overall, 16,694 patients underwent transfemoral TAVR at 444 hospitals and were discharged without anticoagulation. Among these, 13,546 (81.1%) patients were discharged on DAPT, whereas 3,148 patients (18.9%) were discharged on monotherapy. Patients discharged on DAPT versus monotherapy were similar in age, sex, and most comorbid illnesses but had higher rates of coronary artery disease (64.6% vs 52.3%; P<.01) and peripheral artery disease (25.2% vs 22.3%; P<.01). Hospital prescribing patterns varied significantly (median frequency of DAPT 85.7%, interquartile range 94.1%-74.2%). DAPT (vs monotherapy) patients had a similar mortality risk at 1year (adjusted hazard ratio 0.92, 95% CI 0.81-1.05), significantly higher risk for major bleeding (1.48, 1.10-1.99), and similar hazard for stroke (1.04, 0.83-1.31) and MI (1.00, 0.72-1.39). CONCLUSIONS: In the United States, most patients were discharged on DAPT following TAVR. Practice patterns varied significantly among hospitals. Patients discharged with DAPT had a similar adjusted risk of mortality, stroke, and MI compared to antiplatelet monotherapy, although risk for bleeding was significantly higher. Future investigation is needed to define the optimal antiplatelet therapy for patients undergoing TAVR.

Shahian, D. M., T. G. Gleason, R. J. Shemin, J. D. Carroll and M. J. Mack (2018). “TAVR 2.0: Collaborating to Measure, Assure, and Advance Quality.” Ann Thorac Surg Aug 1. [Epub ahead of print].

Full text of this article.

The 2018 TAVR Multisociety Expert Consensus Systems of Care Document is a substantial enhancement of the previous 2012 document, reflecting our continually improving understanding of the requirements for safe and effective use of this technology. Mandatory participation in the TVT registry, direct measures of quality, volume thresholds to assure adequate experience and sample sizes for quality measures, and consistent involvement of MDT’s are critical to the ongoing evolution of transcatheter aortic valve therapy; they are also a paradigm for similar new initiatives in the future. Finally, the Multisociety Writing Committee strongly supports continuation of the TAVR NCD to assure that gains made during the successful initial introduction of this technology are maintained. (Excerpt from unpaginated advanced text; no abstract available.)