Safety and Efficacy of MitraClip in acutely ill (NYHA Class IV) patients with Mitral Regurgitation: Results from the Global EXPAND Study

Mony Shuvy ¹ Ralph Stephan von Bardeleben ² Carmelo Grasso ³ Philip Raake ⁴ Philipp Lurz ⁵ Pooja Singhal ⁶ Lixian Sun ⁶ Jose L. Zamorano ⁷ Federico Asch ⁸ Saibal Kar ⁹ Francesco Maisano ¹⁰

¹Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Israel
²Heart Valve Center in Mainz, Heart Valve Center in Mainz, Germany
³University of Catania, University of Catania, Italy
⁴Department of cardiology at Heidelberg University, Department of cardiology at Heidelberg University, Germany
⁵University of Leipzig, University of Leipzig, Germany
⁶Abbott Vascular, Abbott Vascular, USA
⁷University Complutense in Madrid, University Complutense in Madrid, Spain
⁸MedStar Health Research Institute, MedStar Health Research Institute, USA
⁹Cedars-Sinai Medical Center, Cedars-Sinai Medical Center, USA
¹⁰University Hospital of Zurich, University Hospital of Zurich, Switzerland

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

Methods: EXPAND was a prospective, multi-center international study enrolling consecutive subjects consented to receiving the MitraClip in 60 sites. Collected data included: procedural measures, All-cause mortality and Heart Failure Hospitalization (HFH) rates, Quality of Life (QoL) assessed using KCCQ. The focus of the present analysis was patients with NYHA Class IV.

Results: The study population was comprised of 1024 patients, of them 118 were at NYHA Class IV. Patients at Baseline NYHA Class IV were at higher risk scores, and HFH rates in the prior year, and had significant comorbidities including prior stroke, MI, renal failure, and diabetes, higher rates of secondary MR etiology and more dilated left ventricles. Procudural success was achieved in 92.4% of NYHA Class IV patients and a significant improvement in MR grade was achieved and maintained through 1 year-92.9% of NYHA Class IV patients had mild residual MR (P<0.001). All-cause mortality had HFH were significantly higher in NYHA Class IV patients but were comparable to the MitraClip arm in COAPT trial, and lower than the medical therapy alone arm. Improvement in NYHA Class was observed in NYHA Class IV patients and at 1-year 72.7% of them were at NYHA class I/II, P < 0.0001. QoL was significantly improved at one-year- Δ [95% CI] = 31.18 [24.06, 38.30] P < 0.0001.

Conclusions: MitraClip is safe and effective in treating MR, and is associated with significant improvement in QoL and long-term clinical outcomes in subjects with severe MR and NYHA class IV HF.