Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study

Mony Shuvy, Ralph Stephan von Bardeleben, Carmelo Grasso, Philip Raake, Philipp Lurz, Jose L Zamorano, Federico Asch, Saibal Kar, Francesco Maisano, EXPAND Investigators, Mony Shuvy, Ralph Stephan von Bardeleben, Carmelo Grasso, Philip Raake, Philipp Lurz, Jose L Zamorano, Federico Asch, Saibal Kar, Francesco Maisano, EXPAND Investigators

Abstract

Aim: Patients with severe mitral regurgitation (MR) and acute heart failure (HF) have refractory symptoms without adequate response to medical therapy. The objective of this analysis was to assess the impact of the MitraClip device in acutely ill HF patients, characterized by NYHA Class IV at baseline, in a real-world, contemporary setting.

Methods and results: EXPAND was a prospective, multicenter, international study enrolling patients with MR who consented to receive the MitraClip System at 57 sites globally. The study outcomes included acute procedural success (APS), quality of life, heart failure hospitalizations (HFH), and all-cause mortality. The study population comprised 1,041 patients, with 118 patients having baseline NYHA Class IV, and 922 having baseline NYHA Class I/II/III. NYHA Class IV patients had a significantly higher rate of baseline co-morbidities and secondary MR aetiology compared with NYHA Class I/II/III patients. APS was achieved in 92.4% of NYHA Class IV patients and significant improvement in MR grade to ≤Mild (1+) in 90.7% of subjects at 30 days and 92.9% at 1 year was observed. 1-year-mortality was higher in the NYHA Class IV subjects compared with the NYHA Class I/II/III subjects (29.2% vs. 17.7%, P < 0.01). Significant improvement in functional capacity assessed by NYHA Functional Class and Quality of Life assessed through KCCQ score was observed. At 1 year, 72.6% of NYHA Class IV subjects improved to NYHA Class I/II and ΔKCCQ was 31.2 (24.1, 38.3) compared with baseline.

Conclusion: In the prospective, real-world EXPAND study, MitraClip in patients with severe MR and NYHA Class IV was found to be safe and effective in treating MR, and significantly improving QoL and long-term clinical outcomes.

Trial registration: ClinicalTrials.gov NCT03502811.

Keywords: Class IV heart failure; Mitral regurgitation; Mitral valve repair.

Conflict of interest statement

Dr. Shuvy is a proctor and consultant for Abbott and Edwards Lifesciences. Dr. von Bardeleben has served in unpaid trial activities for Abbott, Edwards Lifesciences, University of Göttingen (IIT), and advisory or speaker bureau for Abbott Cardiovascular, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, Neochord. Dr. Grasso serves as a proctor for Abbott, Boston Scientific, and has received fees as a speaker from Edwards Lifesciences. Dr. Raake has received speaker honoraria from Abbott. Prof. Lurz has served as a consultant, received institutional fees and research grants from Abbott, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr. Zamorano has received speaker honoraria from Pfizer, Amgen, and Daichii, and research grants from Abbott and Edwards Lifesciences. Dr. Asch has no personal disclosures. His work as the director of an Academic Core laboratory is through institutional research grants (MedStar Health) with Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Neovasc, Ancora Heart, Livanova, MVRx, InnovHeart, Polares medical, and Aria CV. Dr. Kar has received grants and institutional research support from Abbott, Boston Scientific, and Edwards Lifesciences, and consulting fees/honoraria from Abbott, Boston Scientific, W.L. Gore and Medtronic. Prof. Maisano has received a grant and/or institutional research support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, Terumo. He received consulting fees, honoraria personal and institutional from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve. He has received royalty income/IP rights from Edwards Lifesciences. He is a shareholder (including share options) of Cardiogard, Magenta, SwissVortex, Transseptal Solutions, Occlufit, 4Tech, Perifect. Dr. Lurz is a consultant for Abbott Vascular, ReCor, Edwards Lifesciences, and Medtronic. He has received institutional research grants from Abbott Vascular, ReCor, and Edwards Lifesciences.

© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Figures

Figure 1
Figure 1
Study population. Distribution of subjects with NYHA Class IV and NYHA Class I/II/III in the EXPAND study.
Figure 2
Figure 2
Change in MR grade by baseline NYHA class. Significant improvement in MR grade was achieved and maintained through 1 year follow‐up for all subjects, irrespective of the baseline NYHA class.
Figure 3
Figure 3
NYHA class and KCCQ changes at 1 year.
Figure 4
Figure 4
Clinical outcomes at 1 year. Mortality and heart failure hospitalization (HFH) by baseline NYHA class.
Figure 5
Figure 5
Clinical outcomes at 1 year by aetiology. Mortality and heart failure hospitalization (HFH) by baseline NYHA class and MR aetiology.

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