1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study

Webb, John G.; Hensey, Mark; Szerlip, Molly; Schäfer, Ulrich; Cohen, Gideon; Kar, Saibal; Makkar, Raj; Kipperman, Robert; Spargias, Konstantinos; O’Neill, William W.; Ng, M.; Fam, Neil; Rinaldi, Michael; Smith, Robert L.; Walters, D.; Raffel, C.; Levisay, Justin; Latib, Azeem; Montorfano, Matteo; Marcoff, Leo; Shrivastava, Maithili; Boone, Robert H.; Gilmore, Suzanne Y.; Feldman, Ted; Lim, D. Scott

doi:10.1016/j.jcin.2020.06.019

Cited by 85 publications

(53 citation statements)

References 24 publications

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“…The PASCAL repair system (Edwards Lifesciences, Irvine, CA) uses two clasps and paddles to achieve coaptation of the mitral valve leaflets, while placing an anatomic spacer to fill the regurgitant orifice area, thus reducing mitral regurgitation. In the multicentre CLASP registry (Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study), 109 patients with symptomatic severe mitral regurgitation (2/3 functional; 1/3 degenerative) underwent PASCAL mitral repair [ 45 ] (Fig. 3 ).…”

Section: Methodsmentioning

confidence: 99%

Advances in Clinical Cardiology 2020: A Summary of Key Clinical Trials

et al. 2021

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Introduction Despite the challenge of a global pandemic, 2020 has been an invaluable year in cardiology research with numerous important clinical trials published or presented virtually at major international meetings. This article aims to summarise these trials and place them in clinical context. Methods The authors reviewed clinical trials presented at major cardiology conferences during 2020 including the American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics and the American Heart Association. Trials with a broad relevance to the cardiology community and those with potential to change current practice were included. Results A total of 87 key cardiology clinical trials were identified for inclusion. New interventional and structural cardiology data included trials evaluating bifurcation percutaneous coronary intervention (PCI) techniques, intravascular ultrasound (IVUS)-guided PCI, instantaneous wave-free (iFR) physiological assessment, new generation stents (DynamX bioadaptor), transcatheter aortic valve implantation (TAVI) in low-risk patients, and percutaneous mitral or tricuspid valve interventions. Preventative cardiology data included new data with proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitors (evolocumab and alirocumab), omega-3 supplements, evinacumab and colchicine in the setting of chronic coronary artery disease. Antiplatelet data included trials evaluating both the optimal length of course following PCI and combination of antiplatelet agents and regimes including combination antithrombotic therapies for patients with atrial fibrillation (AF). Heart failure data included the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors (sotagliflozin, empagliflozin and dapagliflozin) and mavacamten in hypertrophic cardiomyopathy. Electrophysiology trials included early rhythm control in AF and screening for AF. Conclusion This article presents a summary of key clinical cardiology trials during the past year and should be of relevance to both clinicians and cardiology researchers.

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Section: Methodsmentioning

confidence: 99%

Advances in Clinical Cardiology 2020: A Summary of Key Clinical Trials

et al. 2021

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“…Improvement in exercise capacity and quality of life were also significant at 1 year. 27 The PASCAL Transcatheter Valve Repair System and MitraClip System are being compared in patients with both degenerative and functional MR within the CLASPIID/IIF Pivotal Clinical Trial (ClinTrials.Gov: NCT03706833).…”

Section: Pascal Transcatheter Valve Repair Systemmentioning

confidence: 99%

“…Improvement in exercise capacity and quality of life were also significant at 1 year. 27 …”

Section: Introductionmentioning

confidence: 99%

Transcatheter mitral valve repair: an overview of current and future devices

et al. 2021

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The field of transcatheter mitral valve repair (TMVr) for mitral regurgitation (MR) is rapidly evolving. Besides the well-established transcatheter mitral edge-to-edge repair approach, there is also growing evidence for therapeutic strategies targeting the mitral annulus and mitral valve chordae. A patient-tailored approach, careful patient selection and an experienced interventional team is crucial in order to optimise procedural and clinical outcomes. With further data from ongoing clinical trials to be expected, consensus in the Heart Team is needed to address these complexities and determine the most appropriate TMVr therapy, either single or combined, for patients with severe MR.

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“…The PASCAL transcatheter valve repair system harnesses 2 clasps and paddles to achieve plication of the MV leaflets, while placing an anatomic spacer to fill the regurgitant orifice between the native valve leaflets (89). Notably, in the CLASP study enrolling a cohort of 109 patients with severe symptomatic MR (67% secondary MR), the PASCAL system yielded significant MR reduction -with 100% of patients achieving MR ≤2+ and 80% MR ≤1+ sustained at 1 year -and was associated with high survival, low complication rates and enduring improvements in functional status and quality of life at 1 year (90).…”

Section: Future Directionsmentioning

confidence: 99%

Selection of the Optimal Candidate to MitraClip for Secondary Mitral Regurgitation: Beyond Mitral Valve Morphology

Salvatore

Ricci

Dangas

et al. 2021

Front. Cardiovasc. Med.

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Secondary mitral regurgitation (MR) occurs despite structurally normal valve apparatus due to an underlying disease of the myocardium leading to disruption of the balance between tethering and closing forces with ensuing failure of leaflet coaptation. In patients with heart failure (HF) and left ventricular dysfunction, secondary MR is independently associated with poor outcome, yet prognostic benefits related to the correction of MR have remained elusive. Surgery is not recommended for the correction of secondary MR outside coronary artery bypass grafting. Percutaneous mitral valve repair (PMVR) with MitraClip implantation has recently evolved as a new transcatheter treatment option of inoperable or high-risk patients with severe MR, with promising results supporting the extension of guideline recommendations. MitraClip is highly effective in reducing secondary MR in HF patients. However, the derived clinical benefit is still controversial as two randomized trials directly comparing PMVR vs. optimal medical therapy in severe secondary MR yielded virtually opposite conclusions. We reviewed current evidence to identify predictors of PMVR-related outcomes in secondary MR useful to improve the timing and the selection of patients who would derive maximal benefit from MitraClip intervention. Beyond mitral valve anatomy, optimal candidate selection should rely on a comprehensive diagnostic workup and a fine-tuned risk stratification process aimed at (i) recognizing the substantial heterogeneity of secondary MR and its complex interaction with the myocardium, (ii) foreseeing hemodynamic consequences of PMVR, (iii) anticipating futility and (iv) improving symptoms, quality of life and overall survival.

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1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study

Cited by 85 publications

References 24 publications

Advances in Clinical Cardiology 2020: A Summary of Key Clinical Trials

Advances in Clinical Cardiology 2020: A Summary of Key Clinical Trials

Transcatheter mitral valve repair: an overview of current and future devices

Selection of the Optimal Candidate to MitraClip for Secondary Mitral Regurgitation: Beyond Mitral Valve Morphology

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