PMID- 33589411
OWN - NLM
STAT- MEDLINE
DCOM- 20211021
LR  - 20230222
IS  - 1969-6213 (Electronic)
IS  - 1774-024X (Print)
IS  - 1774-024X (Linking)
VI  - 17
IP  - 9
DP  - 2021 Oct 20
TI  - An upfront combined strategy for endovascular haemostasis in transfemoral 
      transcatheter aortic valve implantation.
PG  - 728-735
LID - EIJ-D-20-01125 [pii]
LID - 10.4244/EIJ-D-20-01125 [doi]
AB  - BACKGROUND: Vascular complications still represent an important issue after 
      transcatheter aortic valve implantation (TAVI). AIMS: The aim of this study was 
      to evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) 
      plug-based system on top of suture-based devices (SBDs) for endovascular 
      haemostasis after transfemoral (TF) TAVI. METHODS: From January 2019 to April 
      2020, 332 consecutive patients with preprocedural computed tomography angiography 
      (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 
      30-day major vascular complications and major or life-threatening (LT) bleeding 
      due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 
      pairs), undergoing either isolated SBD or SBD+AS, were matched using the 
      propensity-score method. RESULTS: At 30 days, patients receiving SBD+AS had lower 
      rates of major/LT bleeding (1.6% vs 8.9%, odds ratio [OR] 0.17, 95% confidence 
      interval [CI]: 0.04-0.78; p<0.01) and major vascular complications (1.6% vs 8.9%, 
      OR 0.17, 95% CI: 0.04-0.78; p<0.01). In addition, the use of SBD+AS was 
      associated with a significant cost saving related to the vascular event (mean 
      difference -315.3 euro per patient, 95% CI: -566.4 euro to -64.1 euro; p=0.01), and a 
      higher probability of next-day discharge (NDD) after TAVI (30.9% vs 16.3%, OR 
      2.30, 95% CI: 1.25-4.25; p<0.01). No difference in all-cause 30-day mortality was 
      observed (3.3% vs 1.6% for SBD and SBD+AS groups, respectively, OR 0.49, 95% CI: 
      0.09-2.74; p=0.41). CONCLUSIONS: An upfront combined strategy with an additional 
      AS plug-based device on top of SBDs was shown to reduce major vascular 
      complications and major/LT bleeding due to closure system failure after TF-TAVI. 
      This approach was associated with a cost saving and with a higher probability of 
      NDD compared to the use of isolated SBD. Visual summary. Effectiveness of the 
      upfront combined strategy for endovascular haemostasis in transfemoral 
      transcatheter aortic valve implantation using Angio-Seal on top of a suture-based 
      device (SBD) versus the isolated use of SBD. LT: life-threatening; TF-TAVI: 
      transfemoral transcatheter aortic valve implantation.
FAU - Costa, Giuliano
AU  - Costa G
AD  - Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of 
      Catania, Catania, Italy.
FAU - Valvo, Roberto
AU  - Valvo R
FAU - Picci, Andrea
AU  - Picci A
FAU - Criscione, Enrico
AU  - Criscione E
FAU - Reddavid, Claudia
AU  - Reddavid C
FAU - Motta, Silvia
AU  - Motta S
FAU - Strazzieri, Orazio
AU  - Strazzieri O
FAU - Deste, Wanda
AU  - Deste W
FAU - Giuffrida, Angelo
AU  - Giuffrida A
FAU - Garretto, Valeria
AU  - Garretto V
FAU - Cannizzaro, Maria Teresa
AU  - Cannizzaro MT
FAU - Inserra, Cristina
AU  - Inserra C
FAU - Veroux, Pierfrancesco
AU  - Veroux P
FAU - Giaquinta, Alessia
AU  - Giaquinta A
FAU - Sgroi, Carmelo
AU  - Sgroi C
FAU - Tamburino, Corrado
AU  - Tamburino C
FAU - Barbanti, Marco
AU  - Barbanti M
LA  - eng
PT  - Journal Article
PL  - France
TA  - EuroIntervention
JT  - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on 
      Interventional Cardiology of the European Society of Cardiology
JID - 101251040
SB  - IM
MH  - Aortic Valve/diagnostic imaging/surgery
MH  - *Aortic Valve Stenosis/surgery
MH  - Femoral Artery/diagnostic imaging/surgery
MH  - Hemostasis
MH  - Humans
MH  - *Transcatheter Aortic Valve Replacement/adverse effects
MH  - Treatment Outcome
PMC - PMC9724957
COIS- M. Barbanti is a consultant for Edwards Lifesciences and is an advisory board 
      member for Boston Scientific and Medtronic. C. Tamburino has received speaker 
      honoraria from Medtronic, Abbott Vascular, Edwards Lifesciences and Boston 
      Scientific. The other authors have no conflicts of interest to declare. The Guest 
      Editor reports lectures fees paid to his institution from Amgen, Bayer 
      Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, 
      Edwards Lifesciences, Ferrer, Pfizer, and Novartis, consultancy fees paid to his 
      institution from Boehringer Ingelheim, and grant support from Bayer Healthcare, 
      Boston Scientific, Biotronik, Edwards Lifesciences, GlaxoSmithKline, Medtronic, 
      and Pfizer.
EDAT- 2021/02/17 06:00
MHDA- 2023/02/23 06:00
PMCR- 2022/10/20
CRDT- 2021/02/16 06:01
PHST- 2021/02/17 06:00 [pubmed]
PHST- 2023/02/23 06:00 [medline]
PHST- 2021/02/16 06:01 [entrez]
PHST- 2022/10/20 00:00 [pmc-release]
AID - EIJ-D-20-01125 [pii]
AID - 10.4244/EIJ-D-20-01125 [doi]
PST - ppublish
SO  - EuroIntervention. 2021 Oct 20;17(9):728-735. doi: 10.4244/EIJ-D-20-01125.