Molly Szerlip M.D.

Fam, N.P., von Bardeleben, R.S., Hensey, M., Kodali, S.K., Smith, R.L., Hausleiter, J., Ong, G., Boone, R., Ruf, T., George, I., Szerlip, M., Näbauer, M., Ali, F.M., Moss, R., Bapat, V., Schnitzler, K., Kreidel, F., Ye, J., Deva, D.P., Mack, M.J., Grayburn, P.A., Peterson, M.D., Leon, M.B., Hahn, R.T. and Webb, J.G. (2021). “Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience.” JACC Cardiovasc Interv Feb 5;S1936-8798(20)32387-6. [Epub ahead of print].

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OBJECTIVES: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes. BACKGROUND: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population. METHODS: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up. RESULTS: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis. CONCLUSIONS: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.

Webb, J.G., Hensey, M., Szerlip, M., Schäfer, U., Cohen, G.N., Kar, S., Makkar, R., Kipperman, R.M., Spargias, K., O’Neill, W.W., Ng, M.K.C., Fam, N.P., Rinaldi, M.J., Smith, R.L., Walters, D.L., Raffel, C.O., Levisay, J., Latib, A., Montorfano, M., Marcoff, L., Shrivastava, M., Boone, R., Gilmore, S., Feldman, T.E. and Lim, D.S. (2020). “1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.” JACC Cardiovasc Interv 13(20): 2344-2357.

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OBJECTIVES: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). BACKGROUND: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. METHODS: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. RESULTS: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). CONCLUSIONS: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).

Naidu, S.S., Coylewright, M., Hawkins, B.M., Meraj, P., Morray, B.H., Devireddy, C., Ing, F., Klein, A.J., Seto, A.H., Grines, C.L., Henry, T.D., Rao, S.V., Duffy, P.L., Amin, Z., Aronow, H.D., Box, L.C., Caputo, R.P., Cigarroa, J.E., Cox, D.A., Daniels, M.J., Elmariah, S., Fagan, T.E., Feldman, D.N., Forbes, T.J., Hermiller, J.B., Herrmann, H.C., Hijazi, Z.M., Jeremias, A., Kavinsky, C.J., Latif, F., Parikh, S.A., Reilly, J., Rosenfield, K., Swaminathan, R.V., Szerlip, M., Yakubov, S.J., Zahn, E.M., Mahmud, E., Bhavsar, S.S., Blumenthal, T., Boutin, E., Camp, C.A., Cromer, A.E., Dineen, D., Dunham, D., Emanuele, S., Ferguson, R., Govender, D., Haaf, J., Hite, D., Hughes, T., Laschinger, J., Leigh, S.M., Lombardi, L., McCoy, P., McLean, F., Meikle, J., Nicolosi, M., O’Brien, J., Palmer, R.J., Patarca, R., Pierce, V., Polk, B., Prince, B., Rangwala, N., Roman, D., Ryder, K., Tolve, M.H., Vang, E., Venditto, J., Verderber, P., Watson, N., White, S. and Williams, D.M. (2020). “Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.” Catheter Cardiovasc Interv Aug 25. [Epub ahead of print.].

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The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI’s emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Shah, S., Castro-Dominguez, Y., Gupta, T., Attaran, R., Byrum, G.V., 3rd, Taleb, A., Pettyjohn, A., Bartel, R.C., Szerlip, M., Henry, T.D., Mahmud, E. and Applegate, R.J. (2020). “Impact of the COVID-19 pandemic on interventional cardiology training in the United States.” Catheter Cardiovasc Interv Aug 7;10.1002/ccd.29198. [Epub ahead of print.].

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OBJECTIVES: We sought to determine the effect of COVID-19 related reduction in elective cardiac procedures and acute coronary syndrome presentations on interventional cardiology (IC) training. BACKGROUND: The COVID-19 pandemic has significantly disrupted healthcare in the United States, including cardiovascular services. The impact of COVID-19 on IC fellow training in the United States has not been assessed. METHODS: The Society for Cardiovascular Angiography and Interventions (SCAI) surveyed IC fellows training in both accredited and advanced non-accredited programs, as well as their program directors (PD). RESULTS: Responses were received from 135 IC fellows and 152 PD. All respondents noted reductions in procedural volumes beginning in March 2020. At that time, only 43% of IC fellows had performed >250 PCI. If restrictions were lifted by May 15, 2020 78% of IC fellows believed they would perform >250 PCI, but fell to only 70% if restrictions persisted until the end of the academic year. 49% of IC fellows felt that their procedural competency was impaired by COVID-19, while 97% of PD believed that IC fellows would be procedurally competent at the end of their training. Most IC fellows (65%) noted increased stress at work and at home, and many felt that job searches and/or existing offers were adversely affected by the pandemic. CONCLUSION: The COVID-19 pandemic has substantially affected IC training in the United States, with many fellows at risk of not satisfying current program procedural requirements. These observations support a move to review current IC program requirements and develop mitigation strategies to supplement gaps in education related to reduced procedural volume.

Idris, A., J. L. Christensen, Z. Wang, K. M. Al-Azizi, T. J. George and M. Szerlip (2020). “Echocardiography-Guided Novel Transcatheter Approach for Frozen Cusp of Mitral Bioprosthesis.” JACC Cardiovasc Interv 13(13): e123-e126.

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This is the first reported 3-dimensional TEE-guided transcatheter approach for a frozen cusp of mitral bioprosthesis. Heart team collaboration is key for successful novel transcatheter approaches for complex patients who are at high surgical risk. Three-dimensional TEE plays an essential role in the accurate diagnosis and guidance of structural heart disease procedures. Alternative options and thinking outside the box can be an approach for patients at high surgical risk who have no other options. [No abstract; excerpt from article].