Molly Szerlip M.D.

Szerlip, M., D. N. Feldman, H. D. Aronow, J. C. Blankenship, J. W. Choi, I. Y. Elgendy, S. Elmariah, S. Garcia, B. H. Goldstein, H. Herrmann, R. S. Hira, M. R. Jaff, A. Kalra, E. Kaluski, C. J. Kavinsky, D. M. Kolansky, D. F. Kong, J. C. Messenger, D. Mukherjee, R. A. G. Patel, R. Piana, E. Senerth, M. Shishehbor, G. Singh, V. Singh, P. K. Yadav and D. Cox (2020). “SCAI publications committee manual of standard operating procedures.” Catheter Cardiovasc Interv 2020 Feb 14. [Epub ahead of print].

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Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. The Society for Cardiovascular Angiography and Interventions (SCAI) has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the society’s education, advocacy, and quality improvement initiatives. The publications committee is charged with oversight of SCAI’s clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society’s documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program.

Sengupta, A., S. Zaid, N. Kamioka, J. Terre, M. Miyasaka, S. A. Hirji, M. Hensey, N. Geloo, G. Petrossian, N. Robinson, E. Sarin, L. Ryan, S. H. Yoon, C. W. Tan, O. K. Khalique, S. K. Kodali, T. Kaneko, P. B. Shah, S. C. Wong, A. Salemi, K. Sharma, J. A. Kozina, M. A. Szerlip, C. W. Don, S. Gafoor, M. Zhang, Z. Newhart, S. R. Kapadia, S. L. Mick, A. Krishnaswamy, A. Kini, H. Ahmad, S. L. Lansman, M. J. Mack, J. G. Webb, V. Babaliaros, V. H. Thourani, R. R. Makkar, M. B. Leon, I. George and G. H. L. Tang (2020). “Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve.” JACC Cardiovasc Interv 13(2): 210-216.

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OBJECTIVES: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm(2) have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. METHODS: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 +/- 36.1 mm(2) (range 683.5 to 852.0 mm(2)) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. RESULTS: The mean age was 76.9 +/- 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 +/- 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. CONCLUSIONS: S3 TAVR in annular areas >683 mm(2) is feasible, with favorable mid-term outcomes.

Sengupta, A., S. Zaid, N. Kamioka, J. Terre, M. Miyasaka, S. A. Hirji, M. Hensey, N. Geloo, G. Petrossian, N. Robinson, E. Sarin, L. Ryan, S. H. Yoon, C. W. Tan, O. K. Khalique, S. K. Kodali, T. Kaneko, P. B. Shah, S. C. Wong, A. Salemi, K. Sharma, J. A. Kozina, M. A. Szerlip, C. W. Don, S. Gafoor, M. Zhang, Z. Newhart, S. R. Kapadia, S. L. Mick, A. Krishnaswamy, A. Kini, H. Ahmad, S. L. Lansman, M. J. Mack, J. G. Webb, V. Babaliaros, V. H. Thourani, R. R. Makkar, M. B. Leon, I. George and G. H. L. Tang (2019). “Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve.” JACC Cardiovasc Interv Dec 18. [Epub ahead of print].

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OBJECTIVES: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm(2) have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. METHODS: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 +/- 36.1 mm(2) (range: 683.5 to 852.0 mm(2)) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. RESULTS: The mean age was 76.9 +/- 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 +/- 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. CONCLUSIONS: S3 TAVR in annular areas >683 mm(2) is feasible, with favorable mid-term outcomes.

Chhatriwalla, A. K., S. Vemulapalli, M. Szerlip, S. Kodali, R. T. Hahn, J. T. Saxon, M. J. Mack, G. Ailawadi, J. Rymer, P. Manandhar, A. S. Kosinski and P. Sorajja (2019). “Operator Experience and Outcomes of Transcatheter Mitral Valve Repair in the United States.” J Am Coll Cardiol 74(24): 2955-2965.

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BACKGROUND: Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset. OBJECTIVES: The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr. METHODS: TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and >50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables. RESULTS: All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (less-than-or-equal-to 1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p < 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (less-than-or-equal-to 2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p < 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases. CONCLUSIONS: For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR.

Chhatriwalla, A. K., S. Vemulapalli, M. Szerlip, S. Kodali, R. T. Hahn, J. T. Saxon, M. J. Mack, G. Ailawadi, J. Rymer, P. Manandhar, A. S. Kosinski and P. Sorajja (2019). “Operator Experience and Procedural Results of Transcatheter Mitral Valve Repair in the United States.” Journal of the American College of Cardiology Sep 19. [Epub ahead of print].

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BACKGROUND: Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset. OBJECTIVE: To examine the relationship between operator experience and procedural results of TMVr with MitraClip (Abbott Structural, Santa Clara, CA). METHODS: TMVr device procedures from the STS/ACC TVT Registry were analyzed with operator case number as a continuous and categorical (1-25, 26-50, and >50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables. RESULTS: All TMVr device procedures (n=14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (less-than-or-equal-to 1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p<0.001), while procedural time and procedural complications decreased. Acceptable procedural success (less-than-or-equal-to 2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%, p<0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed up to 200 cases. CONCLUSIONS: For TMVr device proceedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of operator experience was greater when considering the goal of achieving 1+ residual MR.