PMID- 37273745
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230606
IS  - 2474-8714 (Electronic)
IS  - 2474-8706 (Print)
IS  - 2474-8706 (Linking)
VI  - 6
IP  - 2
DP  - 2022 Jun
TI  - One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System 
      for Transcatheter Mitral Valve Repair.
PG  - 100030
LID - 10.1016/j.shj.2022.100030 [doi]
LID - 100030
AB  - 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.
CI  - (c) 2022 The Author(s).
FAU - Moonen, Avalon
AU  - Moonen A
AD  - Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia.
FAU - Chuang, Anthony
AU  - Chuang A
AD  - Flinders University School of Medicine, Adelaide, Australia.
AD  - Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, 
      Canada.
FAU - Simmons, Lisa
AU  - Simmons L
AD  - Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia.
AD  - University of Sydney, Australia.
FAU - Plunkett, Brian T
AU  - Plunkett BT
AD  - Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia.
FAU - Fam, Neil P
AU  - Fam NP
AD  - Department of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada.
FAU - Webb, John G
AU  - Webb JG
AD  - Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, 
      Canada.
FAU - Ng, Martin K C
AU  - Ng MKC
AD  - Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia.
AD  - University of Sydney, Australia.
LA  - eng
PT  - Journal Article
DEP - 20220512
PL  - United States
TA  - Struct Heart
JT  - Structural heart : the journal of the Heart Team
JID - 101743256
PMC - PMC10236790
OTO - NOTNLM
OT  - Mitral regurgitation
OT  - PASCAL Ace system
OT  - Transcatheter edge-to-edge repair
COIS- Drs Fam and Webb have received speaking honoraria, travel support, or grant 
      support from 10.13039/100006520Edwards Lifesciences. Dr Fam is also an Associate 
      Editor of this journal, but his appointment to that role did not occur until 
      after this article had been peer-reviewed. Dr Ng has received travel and grant 
      support from 10.13039/100006520Edwards Lifesciences. All other authors have 
      reported that they have no relationships relevant to the contents of this article 
      to disclose. Our research has adhered to local and international ethical 
      guidelines for human research and all patients provided written and verbal 
      informed consent.
EDAT- 2023/06/05 13:04
MHDA- 2023/06/05 13:05
PMCR- 2022/05/12
CRDT- 2023/06/05 11:50
PHST- 2021/08/09 00:00 [received]
PHST- 2022/03/01 00:00 [revised]
PHST- 2022/03/17 00:00 [accepted]
PHST- 2023/06/05 13:05 [medline]
PHST- 2023/06/05 13:04 [pubmed]
PHST- 2023/06/05 11:50 [entrez]
PHST- 2022/05/12 00:00 [pmc-release]
AID - S2474-8706(22)01780-8 [pii]
AID - 100030 [pii]
AID - 10.1016/j.shj.2022.100030 [doi]
PST - epublish
SO  - Struct Heart. 2022 May 12;6(2):100030. doi: 10.1016/j.shj.2022.100030. 
      eCollection 2022 Jun.