Cardiology

Kodali, S., Hahn, R.T., Eleid, M.F., Kipperman, R., Smith, R., Lim, D.S., Gray, W.A., Narang, A., Pislaru, S.V., Koulogiannis, K., Grayburn, P., Fowler, D., Hawthorne, K., Dahou, A., Deo, S.H., Vandrangi, P., Deuschl, F., Mack, M.J., Leon, M.B., Feldman, T. and Davidson, C.J. (2021). “Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.” J Am Coll Cardiol 77(4): 345-356.

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BACKGROUND: Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options. OBJECTIVES: This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. METHODS: Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. RESULTS: Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). CONCLUSIONS: In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).

Carroll, J.D., Mack, M.J., Vemulapalli, S., Herrmann, H.C., Gleason, T.G., Hanzel, G., Deeb, G.M., Thourani, V.H., Cohen, D.J., Desai, N., Kirtane, A.J., Fitzgerald, S., Michaels, J., Krohn, C., Masoudi, F.A., Brindis, R.G. and Bavaria, J.E. (2021). “STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement.” Ann Thorac Surg 111(2): 701-722.

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The STS-ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR’s evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).

Lindenfeld, J., Abraham, W.T., Grayburn, P.A., Kar, S., Asch, F.M., Lim, D.S., Nie, H., Singhal, P., Sundareswaran, K.S., Weissman, N.J., Mack, M.J. and Stone, G.W. (2021). “Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes: A Secondary Analysis of the COAPT Trial.” JAMA Cardiol Feb 3;e207200. [ Epub ahead of print].

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IMPORTANCE: Transcatheter mitral valve repair (TMVr) plus maximally tolerated guideline-directed medical therapy (GDMT) reduced heart failure (HF) hospitalizations (HFHs) and all-cause mortality (ACM) in symptomatic patients with HF and secondary mitral regurgitation (SMR) compared with GDMT alone in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial but not in a similar trial, Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR), possibly because the degree of SMR relative to the left ventricular end-diastolic volume index (LVEDVi) was substantially lower. OBJECTIVE: To explore contributions of the degree of SMR using the effective regurgitation orifice area (EROA), regurgitant volume (RV), and LVEDVi to the benefit of TMVr in the COAPT trial. DESIGN, SETTING, AND PARTICIPANTS: This post hoc secondary analysis of the COAPT randomized clinical trial performed December 27, 2012, to June 23, 2017, evaluated a subgroup of COAPT patients (group 1) with characteristics consistent with patients enrolled in MITRA-FR (n = 56) (HF with grade 3+ to 4+ SMR, left ventricular ejection fraction of 20%-50%, and New York Heart Association function class II-IV) compared with remaining (group 2) COAPT patients (n = 492) using the end point of ACM or HFH at 24 months, components of the primary end point, and quality of life (QOL) (per the Kansas City Cardiomyopathy Questionnaire overall summary score) and 6-minute walk distance (6MWD). The same end points were evaluated in 6 subgroups of COAPT by combinations of EROA and LVEDVi and of RV relative to LVEDVi. INTERVENTIONS: Interventions were TMVr plus GDMT vs GDMT alone. RESULTS: A total of 548 participants (mean [SD] age, 71.9 [11.2] years; 351 [64%] male) were included. In group 1, no significant difference was found in the composite rate of ACM or HFH between TMVr plus GDMT vs GDMT alone at 24 months (27.8% vs 33.1%, P = .83) compared with a significant difference at 24 months (31.5% vs 50.2%, P < .001) in group 2. However, patients randomized to receive TMVr vs those treated with GDMT alone had significantly greater improvement in QOL at 12 months (mean [SD] Kansas City Cardiomyopathy Questionnaire summary scores: group 1: 18.36 [5.38] vs 0.43 [4.00] points; P = .01; group 2: 16.54 [1.57] vs 5.78 [1.82] points; P < .001). Group 1 TMVr-randomized patients vs those treated with GDMT alone also had significantly greater improvement in 6MWD at 12 months (mean [SD] paired improvement: 39.0 [28.6] vs -48.0 [18.6] m; P = .02). Group 2 TMVr-randomized patients vs those treated with GDMT alone tended to have greater improvement in 6MWD at 12 months, but the difference did not reach statistical significance (mean [SD] paired improvement: 35.0 [7.7] vs 16.0 [9.1] m; P = .11). CONCLUSIONS AND RELEVANCE: A small subgroup of COAPT-resembling patients enrolled in MITRA-FR did not achieve improvement in ACM or HFH at 24 months but had a significant benefit on patient-centered outcomes (eg, QOL and 6MWD). Further subgroup analyses with 24-month follow-up suggest that the benefit of TMVr is not fully supported by the proportionate-disproportionate hypothesis. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01626079.

Grayburn, P.A. and Thomas, J.D. (2021). “Basic Principles of the Echocardiographic Evaluation of Mitral Regurgitation.” JACC Cardiovasc Imaging Jan 13;S1936-878X(20)31101-3. [Epub ahead of print].

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Mitral regurgitation (MR) is a common form of valvular heart disease that is associated with significant morbidity and mortality. Treatment decisions are completely dependent on accurate diagnosis of both mechanism and severity of MR, which can be challenging and is often done incorrectly. Transthoracic echocardiography is the most commonly used imaging test for MR; transesophageal echocardiography is often needed to better define morphology and MR severity, and is essential for guiding transcatheter therapies for MR. Multidetector computed tomography has become the standard to assess whether transcatheter valve replacement is an option because of its ability to assess valve sizing, access, and potential left ventricular outflow tract obstruction. Finally, cine cardiac magnetic resonance has been recommended by recent guidelines to quantify MR severity when the distinction between moderate and severe MR is indeterminate by echocardiography. This paper focuses on the main questions to be answered by imaging techniques and illustrates some common tips, tricks, and pitfalls in the assessment of MR.

Davidson, C.J., Lim, D.S., Smith, R.L., Kodali, S.K., Kipperman, R.M., Eleid, M.F., Reisman, M., Whisenant, B., Puthumana, J., Abramson, S., Fowler, D., Grayburn, P., Hahn, R.T., Koulogiannis, K., Pislaru, S.V., Zwink, T., Minder, M., Dahou, A., Deo, S.H., Vandrangi, P., Deuschl, F., Feldman, T.E. and Gray, W.A. (2021). “Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes.” JACC Cardiovasc Interv 14(1): 41-50.

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OBJECTIVES: The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR). BACKGROUND: Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited. METHODS: In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee. RESULTS: The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p < 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p < 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p < 0.001). CONCLUSIONS: In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457).