Evaluating Mitral TEER in the Management of Moderate Secondary Mitral Regurgitation Among Heart Failure Patients

Anita W Asgar; Gilbert H L Tang; Jason H Rogers; Wolfgang Rottbauer; M Andrew Morse; Paolo Denti; Paul Mahoney; Michael J Rinaldi; Federico M Asch; Jose L Zamorano; Melody Dong; Rong Huang; Joann Lindenfeld; Francesco Maisano; Ralph Stephan von Bardeleben; Saibal Kar; Evelio Rodriguez

doi:10.1016/j.jchf.2024.08.001

Evaluating Mitral TEER in the Management of Moderate Secondary Mitral Regurgitation Among Heart Failure Patients

JACC Heart Fail. 2024 Aug 29:S2213-1779(24)00600-0. doi: 10.1016/j.jchf.2024.08.001. Online ahead of print.

Authors

Anita W Asgar¹, Gilbert H L Tang², Jason H Rogers³, Wolfgang Rottbauer⁴, M Andrew Morse⁵, Paolo Denti⁶, Paul Mahoney⁷, Michael J Rinaldi⁸, Federico M Asch⁹, Jose L Zamorano¹⁰, Melody Dong¹¹, Rong Huang¹¹, Joann Lindenfeld¹², Francesco Maisano¹³, Ralph Stephan von Bardeleben¹⁴, Saibal Kar¹⁵, Evelio Rodriguez⁵

Affiliations

¹ Montreal Heart Institute, Montreal, Quebec, Canada. Electronic address: Anita.asgar@umontreal.ca.
² Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York, USA.
³ University of California-Davis, Sacramento, California, USA.
⁴ Ulm University Heart Center, Department of Cardiology, Ulm, Germany.
⁵ Ascension Saint Thomas, Nashville, Tennessee, USA.
⁶ San Raffaele University Hospital, Milan, Italy.
⁷ University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, Pennsylvania, USA.
⁸ Sanger Heart and Vascular Institute of Cardiothoracic Surgery, Charlotte, North Carolina, USA.
⁹ Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC, USA.
¹⁰ Department of Cardiology, Ramón y Cajal University Hospital, Madrid, Spain.
¹¹ Abbott Structural Heart, Santa Clara, California, USA.
¹² Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹³ Division of Cardiac Surgery and Valve Center, IRCCS Ospedale San Raffaele, Milan, Italy.
¹⁴ Department of Cardiology, University Medical Center of Mainz, Mainz, Germany.
¹⁵ Los Robles Regional, Thousand Oaks, California, USA.

PMID: 39269396
DOI: 10.1016/j.jchf.2024.08.001

Abstract

Background: Moderate secondary mitral regurgitation (SMR) represents a subgroup of heart failure (HF) patients with treatment restricted to medical therapy. Outcomes in patients with moderate SMR treated with mitral transcatheter edge-to-edge repair (M-TEER) are less well known.

Objectives: The aim of this study was to assess the safety and effectiveness of M-TEER in subjects with moderate SMR using the EXPANDed studies.

Methods: One-year outcomes in subjects from the EXPANDed studies (EXPAND [A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices] and EXPAND G4 [A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System] MitraClip studies) with baseline moderate SMR (2+), per echocardiographic core laboratory (ECL) assessment, were compared with subjects with baseline severe SMR (≥3+).

Results: There were 335 subjects with moderate SMR and 525 with severe SMR at baseline per ECL review. Baseline characteristics were similar between the 2 subgroups. After treatment with M-TEER, significant MR reduction was achieved in both groups. Significant left ventricular (LV) reverse remodeling was observed through 1 year, with a >20 mL decrease in LV end-diastolic and end-systolic volumes on average in the moderate SMR group. Significant 1-year improvements in NYHA functional class (>78% NYHA functional class I or II) and quality of life (>20 points on the Kansas City Cardiomyopathy Questionnaire-Overall Summary) were observed in subjects with moderate SMR. Similarly, low rates of major adverse events, all-cause mortality, and HF hospitalizations were observed between the 2 subgroups through 1 year.

Conclusions: In the EXPANDed studies, subjects with moderate SMR treated with M-TEER had improvements similar to subjects with severe SMR in quality of life and positive LV remodeling at 1 year. Future studies are needed to evaluate if M-TEER would be beneficial for HF patients with moderate SMR.

Keywords: MitraClip; mitral valve repair; moderate mitral regurgitation; secondary mitral regurgitation; transcatheter edge-to-edge repair.