Vascular complications with a plug-based vascular closure device after transcatheter aortic valve replacement: Predictors and bail-outs.
Aged, 80 and over
Aortic Valve
/ diagnostic imaging
Aortic Valve Stenosis
/ diagnostic imaging
Catheterization, Peripheral
/ adverse effects
Female
Femoral Artery
/ diagnostic imaging
Hemostatic Techniques
/ adverse effects
Humans
Male
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
Vascular Closure Devices
aortic valve disease
mechanical circulatory support
percutaneous intervention
vascular complications
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 11 2021
01 11 2021
Historique:
revised:
18
11
2020
received:
30
07
2020
accepted:
06
12
2020
pubmed:
4
2
2021
medline:
15
12
2021
entrez:
3
2
2021
Statut:
ppublish
Résumé
The MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking. To evaluate MANTA in a real-world population and identify predictors for vascular complications. All patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre-procedural computed tomography and post-deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow-up according to the VARC-2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all-cause mortality for patients with and without an access site complication. The 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75-85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4-29.7). Access site related major- or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28-98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53-0.93]), low- (OR 3.47 [1.21-10.00]) and high (OR 2.43 [1.16-5.10]) arteriotomies were independent predictors for vascular complications. In this contemporary TAVR population, access-site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off-target punctures were independent predictors.
Sections du résumé
BACKGROUND
The MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking.
AIM
To evaluate MANTA in a real-world population and identify predictors for vascular complications.
METHODS
All patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre-procedural computed tomography and post-deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow-up according to the VARC-2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all-cause mortality for patients with and without an access site complication.
RESULTS
The 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75-85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4-29.7). Access site related major- or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28-98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53-0.93]), low- (OR 3.47 [1.21-10.00]) and high (OR 2.43 [1.16-5.10]) arteriotomies were independent predictors for vascular complications.
CONCLUSION
In this contemporary TAVR population, access-site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off-target punctures were independent predictors.
Identifiants
pubmed: 33533544
doi: 10.1002/ccd.29506
pmc: PMC9292646
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
E737-E745Informations de copyright
© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
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