Molly Szerlip M.D.

Sommer, R.J., Kim, J.H., Szerlip, M., Chandhok, S., Sugeng, L., Cain, C., Kaplan, A.V. and Gray, W.A. (2021). “Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use.” JACC Cardiovasc Interv 14(21): 2368-2374.

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OBJECTIVES: The authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device. BACKGROUND: The CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation. METHODS: Patients with atrial fibrillation at high stroke risk (CHA(2)DS(2)-VASc score ≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6 months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45 days and 1 year. RESULTS: Twenty-two patients (63.7% with CHA(2)DS(2)-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45 days, 1 significant leak (≥5 mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization. CONCLUSIONS: This first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.

Villablanca, P.A., Vemulapalli, S., Stebbins, A., Dai, D., So, C.Y., Eng, M.H., Wang, D.D., Frisoli, T.M., Lee, J.C., Kang, G., Szerlip, M., Ibrahim, H., Staniloae, C., Gaba, P., Lemor, A., Finn, M., Ramakrishna, H., Williams, M.R., Leon, M.B., O’Neill, W.W. and Shah, B. (2021). “Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017.” Circ Cardiovasc Interv 14(11): e009374.

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BACKGROUND: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. METHODS: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. RESULTS: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. CONCLUSIONS: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Naidu, S. S., S. J. Baron, M. H. Eng, S. K. Sathanandam, D. A. Zidar, D. N. Feldman, F. F. Ing, F. Latif, M. J. Lim, T. D. Henry, S. V. Rao, G. D. Dangas, J. B. Hermiller, R. Daggubati, B. Shah, L. Ang, H. D. Aronow, S. Banerjee, L. C. Box, R. P. Caputo, M. G. Cohen, M. Coylewright, P. L. Duffy, A. M. Goldsweig, D. J. Hagler, B. M. Hawkins, Z. M. Hijazi, S. Jayasuriya, H. Justino, A. J. Klein, C. Kliger, J. Li, E. Mahmud, J. C. Messenger, B. H. Morray, S. A. Parikh, J. Reilly, E. Secemsky, M. H. Shishehbor, M. Szerlip, S. J. Yakubov, C. L. Grines, J. Alvarez-Breckenridge, C. Baird, D. Baker, C. Berry, M. Bhattacharya, S. Bilazarian, R. Bowen, K. Brounstein, C. Cameron, R. Cavalcante, C. Culbertson, P. Diaz, S. Emanuele, E. Evans, R. Fletcher, T. Fortune, P. Gaiha, D. Govender, D. Gutfinger, K. Haggstrom, A. Herzog, D. Hite, B. Kalich, A. Kirkland, T. Kohler, H. Laurisden, K. Livolsi, L. Lombardi, S. Lowe, K. Marhenke, J. Meikle, N. Moat, M. Mueller, R. Patarca, J. Popma, N. Rangwala, C. Simonton, J. Stokes, M. Taber, C. Tieche, J. Venditto, N. E. J. West and L. Zinn (2021). “Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 think tank.” Catheter Cardiovasc Interv.

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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 annually for high-level field-wide discussions. The 2021 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. 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 dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

Herrmann, H.C., Cohen, D.J., Hahn, R.T., Babaliaros, V.C., Yu, X., Makkar, R., McCabe, J., Szerlip, M., Kapadia, S., Russo, M., Malaisrie, S.C., Webb, J.G., Szeto, W.Y., Kodali, S., Thourani, V.H., Mack, M.J. and Leon, M.B. (2021). “Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement.” Circ Cardiovasc Interv Jun 16;CIRCINTERVENTIONS120010310. [Epub ahead of print]. Circinterventions120010310.

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BACKGROUND: The potential advantages for conscious sedation (CS) as compared to general anesthesia (GA) have not been evaluated in studies with core laboratory echocardiographic assessments and monitored end points. We compared CS versus GA for SAPIEN 3 transcatheter aortic valve replacement in patients at intermediate- and low-surgical risk. METHODS: This analysis included patients in the PARTNER 2 (Placement of Aortic Transcatheter Valve Trial) intermediate-risk registry and the PARTNER 3 randomized low-risk study. CS was compared to GA with respect to death, stroke, bleeding, paravalvular regurgitation, length of stay, and costs. Outcomes were assessed by a core echocardiographic laboratory, and clinical events were independently adjudicated. RESULTS: Baseline characteristics were similar between the CS and GA groups. Postprocedure hospital length of stay was significantly shorter for CS versus GA both in intermediate-risk patients (4.4±0.2 and 5.2±0.2 days, respectively, P<0.01) and low-risk patients (2.7±0.1 and 3.4±0.2 days, respectively, P<0.001). There were no significant differences between CA and GA patients in either the 30-day or 1-year rates of death, stroke, rehospitalization, or paravalvular aortic regurgitation ≥moderate. In the intermediate-risk cohort, adjusted 30-day health care costs were $3833 lower per patient in the CS group. CONCLUSIONS: The selective use of CS is associated with shorter procedure times, shorter intensive care unit and hospital length of stay, lower costs, and no difference in clinical outcomes to 1 year, including ≥moderate paravalvular regurgitation. Our data demonstrate similar safety profiles with both approaches and support the continued use of CS for most patients undergoing the procedure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03222128 and NCT02675114.

Szerlip, M., Spargias, K.S., Makkar, R., Kar, S., Kipperman, R.M., O’Neill, W.W., Ng, M.K.C., Smith, R.L., Fam, N.P., Rinaldi, M.J., Raffel, O.C., Walters, D.L., Levisay, J., Montorfano, M., Latib, A., Carroll, J.D., Nickenig, G., Windecker, S., Marcoff, L., Cohen, G.N., Schäfer, U., Webb, J.G. and Lim, D.S. (2021). “2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.” JACC Cardiovasc Interv May 7;S1936-8798(21)00675-0. [Epub ahead of print].

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OBJECTIVES: The study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis. BACKGROUND: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established. METHODS: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. RESULTS: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001). CONCLUSIONS: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.