Molly Szerlip M.D.

Posted November 15th 2018

SCAI 2018 Think Tank Proceedings: “What should the role of the surgeon be in TAVR, both as a co-operator and in-patient evaluation for TAVR?

Molly Szerlip M.D.

Molly Szerlip M.D.

Giri, J. S., M. Szerlip, C. Devireddy, D. A. Cox, C. Kavinsky, P. Genereux, S. S. Naidu, C. Bruner, J. Struck, J. Kurz and J. Dunham (2018). “SCAI 2018 Think Tank Proceedings: “What should the role of the surgeon be in TAVR, both as a co-operator and in-patient evaluation for TAVR?” Catheter Cardiovasc Interv Oct 24. [Epub ahead of print].

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The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is held annually bringing together expert opinion from interventional cardiologists, administrative partners, and select members of the cardiovascular industry community in a collaborative venue . . . Over the past decade, transcatheter aortic valve replacement (TAVR) has been promulgated in the United States under unique circumstances; as a paradigm‐shifting procedure in which two operators from different specialties (interventional cardiology and cardiac surgery) are mandated to perform each case as “co‐surgeons” in order to receive Centers of Medicare and Medicaid Services (CMS) reimbursement for services. This is accomplished by a “mandated 62‐modifier”, which represents the CMS designation for a procedure performed by two operators entitling both to a total of 125% (ie, 62.5% each) of the professional fees assigned to the procedure by the CMS fee schedule. While use of 62‐modifiers is relatively common in a variety of complex procedures, TAVR is unique as the only procedure in which use of the 62‐modifer is mandated in all cases by CMS . . . While this has been the structure of TAVR evaluation and performance since its introduction to the US market, there have been tremendous advances in TAVR over the last decade, both related to technology and processes of care. Examples include: fully percutaneous access, moderate sedation, fast track protocols, dramatically reduced device profiles resulting in an overwhelming majority of cases being performed via transfemoral arterial access, and improvements in pacemaker and paravalvular leak rates. Nearly, all of these advances have served to make the procedure simpler, more consistent, and more efficient. Ongoing improvements in technology aim to further simplify the procedure allowing for rapid, accurate and consistent valve delivery by a single operator. These developments compelled us to re‐evaluate the appropriateness of the current system of care. [Four points of consensus from the SCAI discussions are described.] (Excerpt from text, p. 1-2.)


Posted September 15th 2018

TAVR Vs. SAVR in Intermediate-Risk Patients: What Influences Our Choice of Therapy.

Sasha Still, M.D.

Sasha Still, M.D.

Still, S., M. Szerlip and M. Mack (2018). “TAVR Vs. SAVR in Intermediate-Risk Patients: What Influences Our Choice of Therapy.” Curr Cardiol Rep 20(10): 82.

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PURPOSE OF REVIEW: To determine what influences patients and physicians to choose between transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with severe, symptomatic aortic stenosis. RECENT FINDINGS: Advances in transcatheter valve technology, techniques, and trials demonstrating non-inferiority compared to surgical aortic valve replacement (SAVR) have led to expanded eligibility of transcatheter aortic valve replacement (TAVR) to both intermediate-risk patients in clinical practice and low-risk patients in pivotal trials. Since lower-risk individuals tend to be younger and good operative candidates, concerns of valve durability, procedure-related morbidity, and patient survivability require careful consideration. Results from the PARTNER II intermediate risk trials and SURTAVI trials have given us insight into the benefits and potential risks of both treatment modalities. In this article, we review the brief yet remarkable history of TAVR and discuss its role in the treatment of intermediate-surgical-risk patients.


Posted September 15th 2018

Clinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Aortic Valves by 4DCT.

Michael J. Mack M.D.

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].

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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.


Posted August 15th 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.

Michael J. Mack M.D.

Michael J. Mack M.D.

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.

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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.


Posted July 15th 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.

Michael J. Mack M.D.

Michael J. Mack M.D.

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 Jun 26. [Epub ahead of print].

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.