PMID- 35407584
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220415
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 11
IP  - 7
DP  - 2022 Apr 1
TI  - Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech 
      Paravalvular Leak Device for Significant Paravalvular Regurgitation.
LID - 10.3390/jcm11071978 [doi]
LID - 1978
AB  - Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral 
      (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety 
      data were available for 137 patients, who were included in the safety analysis 
      fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full 
      analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral 
      leak) as well as baseline (BL), 180-day or later assessments (2 years). 
      Procedural success (implantation of the device with a proper closure of the PVL, 
      defined as reduction in paravalvular regurgitation of >/=one grade as assessed by 
      echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi 
      PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering 
      from significant or severe heart failure (HF), classified as New York Heart 
      Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 
      2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related 
      blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients 
      and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were 
      reported in 27 patients (19.7%) of the SAF population. The SAEs considered 
      possibly or probably related to the device included device embolization (three 
      patients), residual leak (two patients) and vascular complication (one patient). 
      During follow-up, 12/137 (8.8%) patients died, but none of the deaths was 
      considered to be device-related. Patients implanted with the Occlutech 
      Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical 
      parameters, including NYHA class and a reduced dependency on hemolysis-related 
      blood transfusions.
FAU - Onorato, Eustaquio Maria
AU  - Onorato EM
AUID- ORCID: 0000-0002-6750-5682
AD  - Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
FAU - Alamanni, Francesco
AU  - Alamanni F
AD  - Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
FAU - Muratori, Manuela
AU  - Muratori M
AD  - Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
FAU - Smolka, Grzegorz
AU  - Smolka G
AD  - 3rd Division of Cardiology, Medical University of Silesia, 40-055 Katowice, 
      Poland.
FAU - Wojakowski, Wojtek
AU  - Wojakowski W
AUID- ORCID: 0000-0002-3681-5207
AD  - 3rd Division of Cardiology, Medical University of Silesia, 40-055 Katowice, 
      Poland.
FAU - Pysz, Piotr
AU  - Pysz P
AUID- ORCID: 0000-0003-4390-9882
AD  - 3rd Division of Cardiology, Medical University of Silesia, 40-055 Katowice, 
      Poland.
FAU - Zorinas, Aleksejus
AU  - Zorinas A
AD  - Department of Cardiovascular Medicine, Vilnius University, 01513 Vilnius, 
      Lithuania.
FAU - Zakarkaite, Diana
AU  - Zakarkaite D
AD  - Department of Cardiovascular Medicine, Vilnius University, 01513 Vilnius, 
      Lithuania.
FAU - Eltchaninoff, Helene
AU  - Eltchaninoff H
AD  - Department of Cardiology and Cardiovascular Surgery, Hospital Charles Nicolle, 
      76000 Rouen, France.
FAU - Litzer, Pierre-Yves
AU  - Litzer PY
AD  - Department of Cardiology and Cardiovascular Surgery, Hospital Charles Nicolle, 
      76000 Rouen, France.
FAU - Godart, Francois
AU  - Godart F
AD  - Department of Pediatric Cardiology and Congenital Heart Disease, University of 
      Lille, 59000 Lille, France.
FAU - Calvert, Patrick
AU  - Calvert P
AD  - Department of Cardiology, Papworth Hospital NHS Foundation Trust, Cambridge CB2 
      0AY, UK.
FAU - Christou, Christos
AU  - Christou C
AD  - American Heart Institute, Nicosia 1311, Cyprus.
FAU - Mussayev, Abdurashid
AU  - Mussayev A
AD  - National Research Cardiac Surgery Center, Astana 020000, Kazakhstan.
FAU - Missiroli, Bindo
AU  - Missiroli B
AD  - Gemelli Molise di Campobasso-Fondazione Policlinico Universitario Agostino 
      Gemelli, IRCCS, 86100 Campobasso, Italy.
FAU - Buzaev, Igor
AU  - Buzaev I
AD  - Cardiovascular Department, Bashkir State Medical University, 450008 Ufa, Russia.
FAU - Curello, Salvatore
AU  - Curello S
AD  - USVD Emodinamica, Spedali Civili di Brescia, 25123 Brescia, Italy.
FAU - Tesorio, Tullio
AU  - Tesorio T
AD  - Department of Invasive Cardiology, Clinica Montevergine, 83013 Mercogliano, 
      Italy.
FAU - Bartorelli, Antonio Luca
AU  - Bartorelli AL
AD  - Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
AD  - Department of Biomedical and Clinical Sciences "Luigi Sacco", University of 
      Milan, 20122 Milan, Italy.
LA  - eng
PT  - Journal Article
DEP - 20220401
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC8999580
OTO - NOTNLM
OT  - aortic valve
OT  - device
OT  - hemolysis
OT  - long-term outcomes
OT  - mitral valve
OT  - paravalvular leak
OT  - paravalvular regurgitation
OT  - transcatheter closure
COIS- Eustaquio Maria Onorato is consultant for Occlutech. The remaining authors have 
      no conflict of interest to declare.
EDAT- 2022/04/13 06:00
MHDA- 2022/04/13 06:01
PMCR- 2022/04/01
CRDT- 2022/04/12 01:07
PHST- 2022/02/10 00:00 [received]
PHST- 2022/03/26 00:00 [revised]
PHST- 2022/03/29 00:00 [accepted]
PHST- 2022/04/12 01:07 [entrez]
PHST- 2022/04/13 06:00 [pubmed]
PHST- 2022/04/13 06:01 [medline]
PHST- 2022/04/01 00:00 [pmc-release]
AID - jcm11071978 [pii]
AID - jcm-11-01978 [pii]
AID - 10.3390/jcm11071978 [doi]
PST - epublish
SO  - J Clin Med. 2022 Apr 1;11(7):1978. doi: 10.3390/jcm11071978.