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Background: The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR)., Objectives: This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+., Methods: An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression., Results: In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively)., Conclusions: The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833)., Competing Interests: Funding Support and Author Disclosures The CLASP IID trial is funded by Edwards Lifesciences. Dr Marcoff has served as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, with no direct compensation. Dr Koulogiannis has served as a consultant and advisory board member for Edwards Lifesciences; has served as a speaker for Abbott; has served as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, with no direct compensation. Dr Lilian Aldaia has served as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, with no direct compensation. Dr Mediratta has served as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, with no direct compensation. Dr Chadderdon has served as a consultant for Edwards Lifesciences and Medtronic; and has received research grants from GE Healthcare. Dr Makar has served as a consultant for Boston Scientific and Abbott Vascular. Dr Ruf has received speaker, consulting, and proctoring fees from Abbott Laboratories and Edwards Lifesciences. Dr Nabauer has received speaker, consulting, and proctoring fees from Edwards Lifesciences. Dr Grayburn has received research grants from Abbott Vascular, Boston Scientific, Cardiovalve, Edwards Lifesciences, Medtronic, Neochord, W. L. Gore and Associates, and 4C Medical; and has also served as a consultant and advisory board member for Abbott Vascular, Cardiovalve, Edwards Lifesciences, Medtronic, W. L. Gore and Associates, and 4C Medical. Dr Vannan has received research grants and speaker honoraria from Piedmont Heart Institute for Abbott, Medtronic, Edwards Lifesciences, Philips, Siemens Healthineers, and GE Healthcare. Dr Ender has received institutional honoraria from Edwards Lifesciences, Abbott, and Medela, with no direct compensation. Dr Puthumana has served on the Speakers Bureau and as a training consultant for Abbott Structural and Edwards Lifesciences. Dr Mansoor has served as a consultant for Atricure. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has stock options with Navigate; has held institutional consulting contracts with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has served as a Chief Scientific Officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, with no direct industry compensation for either. Dr Mahmood has served as a consultant for education materials for Abbott Medical and GE Ultrasound. Dr Haeffele has served as a consultant to Edwards Lifesciences. Dr Ong has received speaker fees from Abbott. Dr Schneider has served as a speaker, proctor, and advisor for Edwards Lifesciences and Abbott; and has served as an advisor for Boehringer and Lilly. Dr D. Wang has served as a consultant to Edwards Lifesciences, Abbott Vascular, Materialise, and Boston Scientific. Dr Koss has served as an educational speaker for Abbott and Edwards Lifesciences. Dr Harb has served as a consultant for Abbott, Boston Scientific, and Mitria. Dr Miyasaka has served as a consultant for Abbott. Dr Ivannikova has received speaker fees from Edwards Lifesciences. Dr Mitchel has served on the Abbott Speakers Bureau. Dr Raissi has served as a consultant for Abbott. Dr Kalbacher has received proctor fees from Edwards Lifesciences and PiCardia Ltd; and has received lecture fees from Edwards Lifesciences and Abbott Medical. Dr Ho has served as an advisor for Neochord, Half Moon Medical, and Valgen; and has held institutional consulting contracts with GE Healthcare and Edwards Lifesciences. Dr Smith has served in clinical trial leadership and has received institutional grant and travel support for device evaluation from Edwards Lifesciences; has received institutional grants from Artivion; and has received speaker honoraria from Artivion and Medtronic. Dr Hausleiter has served as a consultant and has received speaker honoraria and institutional research support from Edwards Lifesciences. Dr Lim has served as a consultant for Ancora, LagunaTech, Nyra, Opus, Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Gillam has served as a consultant for Philips, Bracco, Edwards Lifesciences, and Medtronic; and has institutional echocardiography core laboratory contracts from Abbott, Edwards Lifesciences, and Medtronic, with no direct compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The 6-minute walk test (6MWT) is a simple functional test that can predict exercise capacity and is widely employed to assess treatment outcomes. Although mortality with transcatheter mitral valve repair (TMVr) using the MitraClip (Abbott Vascular, Menlo Park, CA) is significantly less than for open mitral valve surgery in high-risk patients, identifying which patient will benefit the most from TMVr remains a concern. There are limited prognostic metrics guiding patient selection and, no studies have reported relationship between prolonged hospitalization and 6MWT. This study aimed to determine if the 6MWT can predict prolonged hospitalization in patients undergoing TMVr by MitraClip., Methods: We retrospectively reviewed 162 patients undergoing 6MWT before TMVr. Patients were divided into three groups according to the 6MWT distance (6MWTD) using the median (6MWTD ≥219 m, 6MWTD <219 m, and Unable to Walk). Multivariate logistic regression model was applied to select the demographic characteristics that were associated with the prolonged hospitalization defined as total length of stay ≥4 days in the study., Results: We found that 6MWT (odds ratio 3.64, 95% confidence interval 2.03-6.52, P < 0.001) was independently associated with prolonged hospitalization after adjustment in multivariate analysis. Area under the curve of 6MWT for predicting prolonged hospitalization was 0.79 (95% confidence interval 0.72-0.85)., Conclusions: Our study demonstrates that 6MWT was independently associated with prolonged hospitalization in patients with TMVr, and has a good discriminatory performance for predicting prolonged hospitalization., (© 2018 Wiley Periodicals, Inc.)

Co-morbidities increase markedly with aging, and they often negatively affect its prognosis. Although mortality with transcatheter mitral valve repair (TMVr) is significantly less than for open mitral valve surgery in patients at high surgical risk, it remains a concern to identify which patients will benefit from this treatment. Some prognostic metrics have been reported to guide better patient selection; however, universal risk stratification measures have not been established. This study aimed to determine if age-adjusted Charlson co-morbidity index (CCI) could predict mortality in patients who underwent TMVr and to assess its discriminatory performance in long-term outcomes. We retrospectively reviewed 222 patients who underwent TMVr, and 7 who died in hospital was excluded. Cox proportional hazard models were applied to select the demographic characteristics that were associated with cumulative mortality. Receiver-operating characteristic analyses were performed for predicting all-cause mortality, and discriminatory performance was assessed. We found that the age-adjusted CCI (hazard ratio 1.33, 95% confidence interval 1.16 to 1.51, p <0.001), New York Heart Association classification, and atrial fibrillation were independently associated with mortality. The age-adjusted CCI demonstrated good discriminative performance for predicting mortality at 3 and 5 years (area under the curve 0.71 and 0.77, respectively) and were greater than those of the Society of Thoracic Surgeons score in receiver-operating characteristic analysis. Kaplan-Meier curve demonstrated that the age-adjusted CCI ≥ 8 had poor prognosis after TMVr. In conclusions, the age-adjusted CCI could predict mortality and had a good discriminative performance for predicting longer term outcomes in patients who underwent TMVr., (Copyright © 2017 Elsevier Inc. All rights reserved.)

We describe a patient at high surgical risk who was successfully treated with a MitraClip (Abbott Vascular, Menlo Park, CA) without transmitral gradient. She received corticosteroid therapy for systemic lupus erythematosus, and progressive mitral stenosis developed late after MitraClip implantation. It gradually increased and reached 23 mm Hg at 28 months after the procedure; during the same period, her dose of prednisone had to be increased owing to lupus flare. Systemic inflammatory disease has the potential to result in mitral valve inflammation and fibrosis, ultimately causing thickening of the tissue bridge and worsening of the mitral valve obstruction. Preprocedural counseling regarding durability may help in this population., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)