Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

Jörg Hausleiter¹, D Scott Lim², Linda D Gillam³, Firas Zahr⁴, Scott Chadderdon⁴, Andrew N Rassi⁵, Raj Makkar⁶, Scott Goldman⁷, Volker Rudolph⁸, James Hermiller⁹, Robert M Kipperman³, Abhijeet Dhoble¹⁰, Richard Smalling¹⁰, Azeem Latib¹¹, Susheel K Kodali¹², Mohamad Lazkani¹³, Joseph Choo¹⁴, Philipp Lurz¹⁵, William W O'Neill¹⁶, Roger Laham¹⁷, Josep Rodés-Cabau¹⁸, Saibal Kar¹⁹, Niklas Schofer²⁰, Brian Whisenant²¹, Ignacio Inglessis-Azuaje²², Stephan Baldus²³, Samir Kapadia²⁴, Konstantinos Koulogiannis³, Leo Marcoff³, Robert L Smith²⁵; PASCAL IID Registry Investigators

Affiliations

¹ Klinikum der Universität München, Munich, Germany. Electronic address: Joerg.Hausleiter@med.uni-muenchen.de.
² University of Virginia Health System Hospital, Charlottesville, Virginia, USA.
³ Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
⁴ Oregon Health and Science University, Portland, Oregon, USA.
⁵ Kaiser Permanente San Francisco Medical Center, San Francisco, California, USA.
⁶ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁷ Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
⁸ Ruhr-Universität Bochum, Bochum, Bad Oeynhausen, Germany.
⁹ St Vincent Heart Center of Indiana, Indianapolis, Indiana, USA.
¹⁰ The University of Texas Health Science Center at Houston, Houston, Texas, USA.
¹¹ Montefiore Medical Center, Bronx, New York, USA.
¹² Columbia University Medical Center, New York, New York, USA.
¹³ UC Health Medical Center of the Rockies, Loveland, Colorado, USA.
¹⁴ The Christ Hospital, Cincinnati, Ohio, USA.
¹⁵ University of Leipzig, Leipzig, Germany.
¹⁶ Henry Ford Hospital, Detroit, Michigan, USA.
¹⁷ Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
¹⁸ Laval Hospital, Quebec City, Quebec, Canada.
¹⁹ Los Robles Regional Medical Center, Thousand Oaks, California, USA.
²⁰ University Heart and Vascular Center Hamburg, Hamburg, Germany.
²¹ Intermountain Medical Center, Salt Lake City, Utah, USA.
²² Massachusetts General Hospital, Boston, Massachusetts, USA.
²³ University Hospital Cologne, Cologne, Germany.
²⁴ Cleveland Clinic Foundation, Cleveland, Ohio, USA.
²⁵ Baylor Scott and White The Heart Hospital Plano, Plano, Texas, USA.

PMID: 36725171
DOI: 10.1016/j.jacc.2022.11.034

Multicenter Study

Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

Jörg Hausleiter et al. J Am Coll Cardiol. 2023.

. 2023 Feb 7;81(5):431-442.

doi: 10.1016/j.jacc.2022.11.034.

Authors

Affiliations

¹ Klinikum der Universität München, Munich, Germany. Electronic address: Joerg.Hausleiter@med.uni-muenchen.de.
² University of Virginia Health System Hospital, Charlottesville, Virginia, USA.
³ Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
⁴ Oregon Health and Science University, Portland, Oregon, USA.
⁵ Kaiser Permanente San Francisco Medical Center, San Francisco, California, USA.
⁶ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁷ Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
⁸ Ruhr-Universität Bochum, Bochum, Bad Oeynhausen, Germany.
⁹ St Vincent Heart Center of Indiana, Indianapolis, Indiana, USA.
¹⁰ The University of Texas Health Science Center at Houston, Houston, Texas, USA.
¹¹ Montefiore Medical Center, Bronx, New York, USA.
¹² Columbia University Medical Center, New York, New York, USA.
¹³ UC Health Medical Center of the Rockies, Loveland, Colorado, USA.
¹⁴ The Christ Hospital, Cincinnati, Ohio, USA.
¹⁵ University of Leipzig, Leipzig, Germany.
¹⁶ Henry Ford Hospital, Detroit, Michigan, USA.
¹⁷ Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
¹⁸ Laval Hospital, Quebec City, Quebec, Canada.
¹⁹ Los Robles Regional Medical Center, Thousand Oaks, California, USA.
²⁰ University Heart and Vascular Center Hamburg, Hamburg, Germany.
²¹ Intermountain Medical Center, Salt Lake City, Utah, USA.
²² Massachusetts General Hospital, Boston, Massachusetts, USA.
²³ University Hospital Cologne, Cologne, Germany.
²⁴ Cleveland Clinic Foundation, Cleveland, Ohio, USA.
²⁵ Baylor Scott and White The Heart Hospital Plano, Plano, Texas, USA.

PMID: 36725171
DOI: 10.1016/j.jacc.2022.11.034

Abstract

Background: Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary.

Objectives: The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy.

Methods: Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee.

Results: The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm², and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001).

Conclusions: The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833).

Keywords: CLASP IID; PASCAL system; challenging mitral valve anatomy; mitral valve transcatheter edge-to-edge repair (M-TEER); small mitral valve; transcatheter mitral valve repair (TMVr).

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Conflict of interest statement

Funding Support and Author Disclosures The PASCAL IID registry is funded by Edwards Lifesciences. Dr Hausleiter is a consultant and receives speaker honoraria and institutional research support from Edwards Lifesciences. Dr Lim is a consultant for Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Gillam is a consultant for Philips, Bracco, and Edwards Lifesciences; and directs an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic, for which she receives no direct compensation. Dr Zahr is a consultant for and receives research grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant for and receives research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Goldman has provided minimally invasive mitral valve observation for Edwards Lifesciences. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller is a consultant and proctor for Edwards Lifesciences. Dr Dhoble is a consultant and proctor for Edwards Lifesciences and Abbott. Dr Smalling receives clinical trial grant support from Edwards Lifesciences, Medtronic, and Abbott; and serves as a consultant for Abbott. Dr Latib is a consultant and serves on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Kodali is a consultant for Admedus, Dura Biotech, TriCares, Phillips, and TriFlo; receives institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and serves on the scientific advisory for and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Lurz receives institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr O’Neill is a consultant for Abiomed, BSCI, and Abbott; and was previously a consultant (expired) for Edwards Lifesciences. Dr Laham is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr Kar is a consultant for Abbott, Medtronic, Boston Scientific, WL Gore, Laminar, Intershunt, and V wave; receives institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; is the co-national principal investigator for the REPAIR MR trial and EXPAND registry; is the co-national principal investigator for the PINNACLE FLX trial and CHAMPION trial; serves on the steering committee for the Triluminate Trial; and is an executive committee member for the RELIEVE HF trial. Dr Schofer receives travel support from Edwards Lifesciences and Abbott/St Jude Medical; has received speaking honoraria from Edwards Lifesciences and Boston Scientific; and is a consultant for Edwards Lifesciences and Abbott. Dr Inglessis-Azuaje is a proctor and serves as a lecturer for Edwards Lifesciences; is a consultant and proctor for Medtronic; and is a lecturer for Boston Scientific. Dr Baldus receives research funding from Abbott; and has received lecturing fees from Edwards Lifesciences, Abbott and Medtronic. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and is a speaker for Abbott. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott, for which he receives no direct compensation. Dr Smith is on the CLASP IID trial leadership team and receives institutional grant and travel support for device evaluation from Edwards Lifesciences; receives institutional grants from Artivion; and received honoraria for speaking from Artivion and Medtronic. Dr Rodés-Cabau receives institutional research grants and speaker fees from Edwards Lifesciences. Dr Whisenant is a consultant for Edwards Lifesciences and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation With Complex Mitral Valve Anatomy.
Joseph MS, Bach DS. Joseph MS, et al. J Am Coll Cardiol. 2023 Feb 7;81(5):443-445. doi: 10.1016/j.jacc.2022.11.033. J Am Coll Cardiol. 2023. PMID: 36725172 No abstract available.

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Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

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Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

Authors

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Conflict of interest statement

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