Contemporary Clinical Outcomes with MitraClip™ (NTR/XTR) System - Core-lab Echo Results from +1000 Patient the Global EXPAND Study

Q: What was the purpose of analyzing the Global EXPAND Study echo and clinical adjudication data?

To report echo core-laboratory and Clinical Event Committee adjudicated performance and safety outcomes for MitraClip NTR and XTR systems in the Global EXPAND Study.

Q: How were MR severity assessments standardized after clip placement?

Baseline MR severity followed ASE Guidelines, and post-clip MR severity used a multi-parametric algorithm derived from ASE Guidelines, integrating MR grade determinants such as color Doppler area, PV flow, and vena contracta.

Q: What key endpoints were evaluated in the study?

The study assessed MR severity, procedural measures, and major adverse events, along with quality of life using the KCCQ and functional capacity using NYHA class.

Aug 28, 2026

Upload by Anda

Analyses of the global EXPAND Study evaluate echo core-laboratory and Clinical Event Committee adjudicated performance and safety for the MitraClip NTR and XTR systems in real-world practice. The prospective multi-center single-arm post-market observational study enrolled at least 1000 consecutive subjects across up to 60 sites. Key outcomes included MR severity, procedural measures, major adverse events, quality of life by KCCQ, and functional capacity by NYHA class, with measurement consistency ensured by core laboratories and a multi-parametric ASE-based MR assessment algorithm.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages14

Reading Time35 min

AccessFree to download

Why this study

MitraClip system features

What did we study?

Study design and objectives

Key outcome measures

Data adjudication

How was the study executed?

Echo measurement consistency

Post-clip MR assessment algorithm

Baseline characteristics

Procedural outcomes vs previous studies

Contemporary Clinical Outcomes with MitraClip™(NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study Wolfgang Rottbauer, Mirjam Kessler, Mathew Williams, Paul Mahoney, Ralph Stephan von Bardeleben, Matthew J. Price, Carmelo Grasso, Jose L. Zamorano, Federico M. Asch, Francesco Maisano, and Saibal Kar Potential conflicts of interest Wolfgang Rottbauer Speaker's name : Wolfgang Rottbauer ☑ I do not have any potential conflict of interest to report Why this study? Wolfgang Rottbauer • Abbott introduced an additional implant size with the next generation MitraClip NTR and XTR Systems in 2018. • EXPAND Study was initiated to evaluate real-world clinical experience and outcomes associated with use of the MitraClip NTRand XTR Systems. MitraClip NTR Identical to Original MitraClip NT and Classic size with improved delivery system MitraClip XTR Longer arms for easier grasp and better reach, with an improved delivery catheter system Wolfgang Rottbauer What did we study? EXPAND was a prospective, Multi-center, Single Arm, International, PostMarket, Real World, Observational Study. A minimum of 1000 consecutive subjects consented to receiving the MitraClip NTR/XTR at up to 60 sites Key Outcome Measures: • MR Severity, Procedural Measures, MAE • Quality of Life (QoL) assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ), • Functional capacity assessed using New York Heart Association (NYHA) functional class Data Adjudication: • Clinical Event Committee (CEC) for adjudication of adverse events • Echocardiographic Core Laboratory (ECL) for echo measures The primary objective of the present analyses was to report on the Echo Core Lab and Clinical Events Committee adjudicated performance and safety outcomes of MitraClip NTR and XTR Systems in the Global EXPAND Study. How was the study executed? Wolfgang Rottbauer • Two ELCs utilized to ensure consistency of measurements across sites. • Baseline MR Severity assessed based on ASE Guidelines*, and a multi-parametric algorithm adopted from ASE Guidelines used for post-clip MR severity. | Post-Clip MR Assessment Algorithm | | | | | --- | --- | --- | --- | | MR Grade | Color Doppler Area Size | PV flow | Vena Contracta | | 1+, Mild | Central and small, (<4 cm2 or <10% of the LA area) | Systolic dominant | <0 .5 cm | | 2+,
Moderate | Central and moderate (4-6 cm2 or 10- 30% of the LA area) | Diastolic dominant | | | 3+,
Moderate
to Severe | Central, large (6-8 cm2 or 30-40% of the LA area) or eccentric reaching 1 PV. | All diastolic
(systolic blunting) | ≥0 .5 cm | | 4+, Severe | Eccentric, large (≥8 cm2 or ≥40% of the LA area), or eccentric reaching the second PV | Systolic flow reversal | | *Zoghbi et al. J Am Soc Echocardiogr 2003;16:777-802, 2017;30:303-371, 2019;32:431-475 Baseline Characteristics Wolfgang Rottbauer | Demographics, Comorbidities, Echo Measures* | Primary MR (N=422) | Secondary MR
(N=413) | Overall (N=1041) | | --- | --- | --- | --- | | Age (years) | 79.5 ± 9.4 | 74.7 ± 10.1 | 77.3 ± 9.7 | | Male | 52.1%(220) | 58.4%(241) | 54.9%(571) | | Body Mass Index (kg/m2) | 25.2 ± 4.8 | 26.0 ± 4.9 | 25.9 ± 5.1 | | EuroSCORE II | 5.9 ± 5.6 | 9.8 ± 9.4 | 8.1 ± 8.0 | | STS Repair Score | 5.5 ± 5.4 | 7.2 ± 7.3 | 6.3 ± 6.3 | | Cardiac Arrhythmia | 60.5%(254) | 68.8%(282) | 65.1%(674) | | o Atrial Fibrillation | 92.9%(235) | 88.2%(247) | 91.5%(614) | | Renal Failure | 28.2%(119) | 47.1%(192) | 36.1%(374) | | Diabetes | 19.2%(261) | 29.5%(120) | 25.4%(261) | | Dyslipidemia | 52.5%(219) | 61.4%(245) | 57.2%(582) | | Hypertension | 79.5%(334) | 84.1%(345) | 82.9%(859) | | Prior HF Hospitalization within 1 year | 43.2%(164) | 64.8%(248) | 53.7%(502) | | Prior Myocardial Infarction | 13.6 (46) | 35.8%(145) | 24.2%(246) | | Effective Regurgitant Orifice Area (EROA, cm2) | 0.40± 0.21 | 0.30± 0.12 | 0.35± 0.18 | | Baseline TR of 3+ or 4+ | 22.8% | 19.6% | 21.5% | | Left Ventricular

FAQs

What was the purpose of analyzing the Global EXPAND Study echo and clinical adjudication data?

To report echo core-laboratory and Clinical Event Committee adjudicated performance and safety outcomes for MitraClip NTR and XTR systems in the Global EXPAND Study.

How were MR severity assessments standardized after clip placement?

Baseline MR severity followed ASE Guidelines, and post-clip MR severity used a multi-parametric algorithm derived from ASE Guidelines, integrating MR grade determinants such as color Doppler area, PV flow, and vena contracta.

What key endpoints were evaluated in the study?

The study assessed MR severity, procedural measures, and major adverse events, along with quality of life using the KCCQ and functional capacity using NYHA class.

Aug 28, 2026

Upload by Anda