PMID- 37890011
OWN - NLM
STAT- MEDLINE
DCOM- 20240104
LR  - 20240321
IS  - 1522-726X (Electronic)
IS  - 1522-1946 (Linking)
VI  - 103
IP  - 1
DP  - 2024 Jan
TI  - Outcomes of patients undergoing edge-to-edge mitral valve repair with the Edwards 
      PASCAL transcatheter valve repair system under conscious sedation.
PG  - 137-146
LID - 10.1002/ccd.30866 [doi]
AB  - BACKGROUND: The development of the PASCAL transcatheter valve repair system for 
      treating mitral regurgitation (MR) greatly extends therapeutic options. AIMS: To 
      assess the safety, efficacy, and time efficiency of the PASCAL system in 
      transcatheter edge-to-edge repair (TEER) under conscious sedation (CS). METHODS: 
      This is a retrospective, two-center, German registry study consisting of 211 
      patients who underwent TEER using the PASCAL system under CS. The endpoints were 
      to assess (1) technical, device, and procedural success as per Mitral Valve 
      Academic Research Consortium (MVARC), (2) conversion rate to general anesthesia 
      (GA), (3) hospital length of stay (LoS), (4) New York Heart Association (NYHA) 
      class, and (5) MR compared to baseline at 30-day. RESULTS: A total of 211 
      patients with a mean age of 78.4 +/- 8.9 years, with 51.4% being female and 86.7% 
      belonging to NYHA functional class III/IV and EuroSCORE II 6.3 +/- 4.9%, were 
      enrolled. Procedural success attained was 96.9%, and six patients (2.8%) required 
      conversion from CS to GA. At 30 days follow-up, a significant improvement in MR 
      was found in 96 patients (54.2%) patients with 0/1 grade MR and 45 patients 
      (29.5%) were in NYHA functional class III + IV. Moreover, TEER under CS has a 
      short hospital LoS (6.71 +/- 5.29 days) and intensive care unit LoS (1.34 +/- 3.49 
      days) with a 2.8% mortality rate. CONCLUSIONS: Performing TEER with the PASCAL 
      system under CS resulted in appreciable (96.9%) procedural success with low 
      mortality and is a safe and promising alternative to GA with positive clinical 
      outcomes.
CI  - (c) 2023 The Authors. Catheterization and Cardiovascular Interventions published by 
      Wiley Periodicals LLC.
FAU - Geisler, Tobias
AU  - Geisler T
AD  - University Hospital Tubingen, Tubingen, Germany.
FAU - Schreieck, Juergen
AU  - Schreieck J
AD  - University Hospital Tubingen, Tubingen, Germany.
FAU - Euper, Miriam
AU  - Euper M
AD  - University Hospital Tubingen, Tubingen, Germany.
FAU - Zdanyte, Monika
AU  - Zdanyte M
AD  - University Hospital Tubingen, Tubingen, Germany.
FAU - Goldschmied, Andreas
AU  - Goldschmied A
AD  - University Hospital Tubingen, Tubingen, Germany.
FAU - Gawaz, Meinrad
AU  - Gawaz M
AD  - University Hospital Tubingen, Tubingen, Germany.
FAU - Bramlage, Peter
AU  - Bramlage P
AD  - Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
FAU - Haurand, Jean M
AU  - Haurand JM
AD  - Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital, 
      Duesseldorf, Germany.
FAU - Kelm, Malte
AU  - Kelm M
AD  - Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital, 
      Duesseldorf, Germany.
FAU - Horn, Patrick
AU  - Horn P
AUID- ORCID: 0000-0002-5260-1321
AD  - Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital, 
      Duesseldorf, Germany.
LA  - eng
GR  - Edwards Lifesciences/
PT  - Journal Article
DEP - 20231027
PL  - United States
TA  - Catheter Cardiovasc Interv
JT  - Catheterization and cardiovascular interventions : official journal of the 
      Society for Cardiac Angiography & Interventions
JID - 100884139
SB  - IM
MH  - Humans
MH  - Female
MH  - Aged
MH  - Aged, 80 and over
MH  - Male
MH  - Mitral Valve/diagnostic imaging/surgery
MH  - Conscious Sedation/adverse effects
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - *Mitral Valve Insufficiency/diagnostic imaging/surgery
MH  - *Heart Valve Prosthesis Implantation
MH  - Cardiac Catheterization
OTO - NOTNLM
OT  - conscious sedation
OT  - general anesthesia
OT  - intensive care unit
OT  - length of stay
OT  - transcatheter mitral valve repair or replacement
EDAT- 2023/10/27 18:42
MHDA- 2024/01/04 11:43
CRDT- 2023/10/27 14:33
PHST- 2023/08/28 00:00 [revised]
PHST- 2023/05/22 00:00 [received]
PHST- 2023/10/05 00:00 [accepted]
PHST- 2024/01/04 11:43 [medline]
PHST- 2023/10/27 18:42 [pubmed]
PHST- 2023/10/27 14:33 [entrez]
AID - 10.1002/ccd.30866 [doi]
PST - ppublish
SO  - Catheter Cardiovasc Interv. 2024 Jan;103(1):137-146. doi: 10.1002/ccd.30866. Epub 
      2023 Oct 27.