Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.
JACC Cardiovasc Imaging
; 17(5): 471-485, 2024 May.
Article
in En
| MEDLINE
| ID: mdl-38099912
ABSTRACT
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).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Severity of Illness Index
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Cardiac Catheterization
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Predictive Value of Tests
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Heart Valve Prosthesis Implantation
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Recovery of Function
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Mitral Valve
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Mitral Valve Insufficiency
Limits:
Aged
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Aged80
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Female
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Humans
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Male
Language:
En
Journal:
JACC Cardiovasc Imaging
Journal subject:
ANGIOLOGIA
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CARDIOLOGIA
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DIAGNOSTICO POR IMAGEM
Year:
2024
Document type:
Article
Publication country:
EEUU
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ESTADOS UNIDOS
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ESTADOS UNIDOS DA AMERICA
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EUA
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UNITED STATES
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UNITED STATES OF AMERICA
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US
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USA