PMID- 35170230
OWN - NLM
STAT- MEDLINE
DCOM- 20220325
LR  - 20220325
IS  - 2055-5822 (Electronic)
IS  - 2055-5822 (Linking)
VI  - 9
IP  - 2
DP  - 2022 Apr
TI  - One-year results following PASCAL-based or MitraClip-based mitral valve 
      transcatheter edge-to-edge repair.
PG  - 853-865
LID - 10.1002/ehf2.13849 [doi]
AB  - AIMS: Mitral valve transcatheter edge-to-edge repair (TEER) has been established 
      as a suitable alternative to mitral valve surgery in patients with severe mitral 
      regurgitation (MR) and high surgical risk. The PASCAL system represents a novel 
      device, potentially augmenting the toolkit for TEER. The aim of this study was to 
      assess and compare short and 1 year safety and efficacy of the PASCAL and 
      MitraClip systems for TEER. METHODS AND RESULTS: Procedural, short, and 1 year 
      outcomes of a 1:2 propensity-matched cohort including 41 PASCAL and 82 MitraClip 
      cases were investigated. Matching was based on clinical, laboratory, 
      echocardiographic, and functional characteristics. The primary endpoints assessed 
      were procedural success [as defined by the Mitral Valve Academy Research 
      Consortium (MVARC)], residual MR, functional class, and a composite endpoint 
      comprising death, heart failure hospitalization, and mitral valve 
      re-intervention. We found for the PASCAL and the matched MitraClip cohort no 
      significant differences in MVARC defined technical (90.2% vs. 95.1%, P = 0.44), 
      device (90.2% vs. 89.0%, P = 1.0), or procedural (87.8% vs. 80.5%, P = 0.45) 
      success rates. Accordingly, the overall MR reduction and improvement in New York 
      Heart Association (NYHA) class were comparable (1 year follow-up: MR </= 2 95% vs. 
      93.6%, P = 1.0; NYHA </= 2 57.1% vs. 66.7%, P = 0.59). The composite outcome 
      revealed no statistically significant difference between both devices (1 year 
      follow-up: 31.7% vs. 37.8%, P = 0.55). Interestingly, we found at both short and 
      1 year follow-up a significantly higher rate of patients with none or trace MR in 
      the PASCAL-treated cohort (short follow-up: 17.9% vs. 0%, P = 0.0081; 1 year 
      follow-up: 25% vs. 0%, P = 0.0016). Conversely, the rate of aborted device 
      implantations due to an elevated transmitral gradient was higher in PASCAL 
      interventions (9.8% vs. 1.2%, P = 0.04). CONCLUSIONS: Transcatheter edge-to-edge 
      repair using the PASCAL or MitraClip device results in favourable and comparable 
      outcomes regarding safety, efficacy, and clinical improvement after 1 year.
CI  - (c) 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on 
      behalf of European Society of Cardiology.
FAU - Geis, Nicolas A
AU  - Geis NA
AD  - Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, 
      Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
FAU - Schlegel, Philipp
AU  - Schlegel P
AD  - Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, 
      Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
AD  - DZHK (German Centre for Cardiovascular Research), Partner Site 
      Heidelberg/Mannheim, Heidelberg, Germany.
FAU - Heckmann, Markus B
AU  - Heckmann MB
AD  - Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, 
      Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
AD  - DZHK (German Centre for Cardiovascular Research), Partner Site 
      Heidelberg/Mannheim, Heidelberg, Germany.
FAU - Katus, Hugo A
AU  - Katus HA
AD  - Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, 
      Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
AD  - DZHK (German Centre for Cardiovascular Research), Partner Site 
      Heidelberg/Mannheim, Heidelberg, Germany.
FAU - Frey, Norbert
AU  - Frey N
AD  - Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, 
      Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
AD  - DZHK (German Centre for Cardiovascular Research), Partner Site 
      Heidelberg/Mannheim, Heidelberg, Germany.
FAU - Crespo Lopez, Patricia
AU  - Crespo Lopez P
AD  - Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, 
      Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
FAU - Raake, Philip W J
AU  - Raake PWJ
AD  - Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, 
      Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
AD  - DZHK (German Centre for Cardiovascular Research), Partner Site 
      Heidelberg/Mannheim, Heidelberg, Germany.
LA  - eng
PT  - Journal Article
DEP - 20220215
PL  - England
TA  - ESC Heart Fail
JT  - ESC heart failure
JID - 101669191
SB  - IM
MH  - *Cardiac Surgical Procedures
MH  - *Heart Valve Prosthesis Implantation
MH  - Humans
MH  - Mitral Valve/diagnostic imaging/surgery
MH  - *Mitral Valve Insufficiency/diagnosis/surgery
MH  - Treatment Outcome
PMC - PMC8934931
OTO - NOTNLM
OT  - MitraClip
OT  - Mitral regurgitation
OT  - PASCAL
OT  - TEER
OT  - Transcatheter mitral valve edge-to-edge repair
COIS- N.A.G., P.S., and P.W.J.R. are investigators in the RESHAPE-HF 1, RESHAPE-HF 2, 
      and the CLASP IID/IIF trial. P.W.J.R. has received speaker honoraria from Abbott 
      Cardiovascular. N.F., P.S., and P.W.J.R. received speaker honoraria from Edwards 
      Lifesciences. All other authors have reported that they have no relationships 
      relevant to the contents of this paper to disclose.
EDAT- 2022/02/17 06:00
MHDA- 2022/03/26 06:00
PMCR- 2022/02/15
CRDT- 2022/02/16 05:54
PHST- 2021/12/21 00:00 [revised]
PHST- 2021/10/11 00:00 [received]
PHST- 2022/02/04 00:00 [accepted]
PHST- 2022/02/17 06:00 [pubmed]
PHST- 2022/03/26 06:00 [medline]
PHST- 2022/02/16 05:54 [entrez]
PHST- 2022/02/15 00:00 [pmc-release]
AID - EHF213849 [pii]
AID - 10.1002/ehf2.13849 [doi]
PST - ppublish
SO  - ESC Heart Fail. 2022 Apr;9(2):853-865. doi: 10.1002/ehf2.13849. Epub 2022 Feb 15.