One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair
Background: Continued development of transcatheter mitral repair technologies is needed to address the large and diverse population of high-risk patients with symptomatic mitral regurgitation (MR). The new PASCAL Ace implant system, with its narrower profile, complements the original PASCAL transcat...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-06-01
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| Series: | Structural Heart |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2474870622017808 |
| _version_ | 1818066489818742784 |
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| author | Avalon Moonen, MBBS Anthony Chuang, MBBS Lisa Simmons, MBBS, PhD Brian T. Plunkett, MBChB Neil P. Fam, MD John G. Webb, MD Martin K.C. Ng, MBBS, PhD |
| author_facet | Avalon Moonen, MBBS Anthony Chuang, MBBS Lisa Simmons, MBBS, PhD Brian T. Plunkett, MBChB Neil P. Fam, MD John G. Webb, MD Martin K.C. Ng, MBBS, PhD |
| author_sort | Avalon Moonen, MBBS |
| collection | DOAJ |
| description | Background: Continued development of transcatheter mitral repair technologies is needed to address the large and diverse population of high-risk patients with symptomatic mitral regurgitation (MR). The new PASCAL Ace implant system, with its narrower profile, complements the original PASCAL transcatheter valve repair system. The aim of this study is to report 1-year outcomes from the early, compassionate-use observational experience with the novel PASCAL Ace implant system. Methods: After heart team assessment, adults with symptomatic moderate-to-severe (3+) or severe (4+) MR despite optimal medical therapy were treated under compassionate use at 3 hospitals internationally. Data were prospectively collected, and outcomes were assessed over a 12-month follow-up period. Results: Seventeen patients (mean age 76 years, 65% male, mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score 9.6) were treated. MR etiology was degenerative in 29%, functional in 65%, and mixed in 6%; 59% were in New York Heart Association (NYHA) class III-IV. Technical success was achieved in 100%, and procedural success in 94%. At 1 year, MR grade ≤2+ was achieved in 93% (p < 0.001) with 88% survival rate and 94% free from heart failure hospitalization. The composite major adverse event rate was 6% and 100% of patients had ≤NYHA class II symptoms (p < 0.001). Conclusions: At 1 year, the PASCAL Ace implant system demonstrated feasibility in this early, compassionate use experience in a small group of symptomatic patients with anatomically complex MR. The unique features of the PASCAL Ace implant may expand the treatable MR population. |
| first_indexed | 2024-12-10T15:08:36Z |
| format | Article |
| id | doaj.art-5e24bfae54014683b935be633bc387da |
| institution | Directory Open Access Journal |
| issn | 2474-8706 |
| language | English |
| last_indexed | 2024-12-10T15:08:36Z |
| publishDate | 2022-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Structural Heart |
| spelling | doaj.art-5e24bfae54014683b935be633bc387da2022-12-22T01:43:59ZengElsevierStructural Heart2474-87062022-06-0162100030One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve RepairAvalon Moonen, MBBS0Anthony Chuang, MBBS1Lisa Simmons, MBBS, PhD2Brian T. Plunkett, MBChB3Neil P. Fam, MD4John G. Webb, MD5Martin K.C. Ng, MBBS, PhD6Department of Cardiology, Royal Prince Alfred Hospital, Sydney, AustraliaFlinders University School of Medicine, Adelaide, Australia; Department of Cardiology, St. Paul’s Hospital, Vancouver, British Columbia, CanadaDepartment of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia; University of Sydney, AustraliaDepartment of Cardiology, Royal Prince Alfred Hospital, Sydney, AustraliaDepartment of Cardiology, St. Michael’s Hospital, Toronto, Ontario, CanadaDepartment of Cardiology, St. Paul’s Hospital, Vancouver, British Columbia, CanadaDepartment of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia; University of Sydney, Australia; Address correspondence to: Martin K.C. Ng, MBBS, PhD, Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, Sydney, NSW 2050, Australia.Background: Continued development of transcatheter mitral repair technologies is needed to address the large and diverse population of high-risk patients with symptomatic mitral regurgitation (MR). The new PASCAL Ace implant system, with its narrower profile, complements the original PASCAL transcatheter valve repair system. The aim of this study is to report 1-year outcomes from the early, compassionate-use observational experience with the novel PASCAL Ace implant system. Methods: After heart team assessment, adults with symptomatic moderate-to-severe (3+) or severe (4+) MR despite optimal medical therapy were treated under compassionate use at 3 hospitals internationally. Data were prospectively collected, and outcomes were assessed over a 12-month follow-up period. Results: Seventeen patients (mean age 76 years, 65% male, mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score 9.6) were treated. MR etiology was degenerative in 29%, functional in 65%, and mixed in 6%; 59% were in New York Heart Association (NYHA) class III-IV. Technical success was achieved in 100%, and procedural success in 94%. At 1 year, MR grade ≤2+ was achieved in 93% (p < 0.001) with 88% survival rate and 94% free from heart failure hospitalization. The composite major adverse event rate was 6% and 100% of patients had ≤NYHA class II symptoms (p < 0.001). Conclusions: At 1 year, the PASCAL Ace implant system demonstrated feasibility in this early, compassionate use experience in a small group of symptomatic patients with anatomically complex MR. The unique features of the PASCAL Ace implant may expand the treatable MR population.http://www.sciencedirect.com/science/article/pii/S2474870622017808Mitral regurgitationPASCAL Ace systemTranscatheter edge-to-edge repair |
| spellingShingle | Avalon Moonen, MBBS Anthony Chuang, MBBS Lisa Simmons, MBBS, PhD Brian T. Plunkett, MBChB Neil P. Fam, MD John G. Webb, MD Martin K.C. Ng, MBBS, PhD One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair Structural Heart Mitral regurgitation PASCAL Ace system Transcatheter edge-to-edge repair |
| title | One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair |
| title_full | One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair |
| title_fullStr | One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair |
| title_full_unstemmed | One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair |
| title_short | One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair |
| title_sort | one year outcomes of early compassionate use of the pascal ace implant system for transcatheter mitral valve repair |
| topic | Mitral regurgitation PASCAL Ace system Transcatheter edge-to-edge repair |
| url | http://www.sciencedirect.com/science/article/pii/S2474870622017808 |
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