EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2016
Feasibility and safety of balloon-expandable transcatheter aortic valve implantation with moderate or without predilatation.
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Abramowitz Yigal, Jilaihawi Hasan, Chakravarty Tarun, Kashif Mohammad, Matar George, Hariri Babak, Patel Jigar, Sharma Rahul P, Cheng Wen, Makkar Raj R
Аннотация
AIMS: Aortic valve preparation by performing balloon aortic valvuloplasty (BAV) has always been considered mandatory during transcatheter aortic valve implantation (TAVI) procedures. We aimed to investigate the feasibility and safety of performing balloon-expandable TAVI with moderate or with no predilatation (PD).
METHODS AND RESULTS: Overall, 121 patients underwent TAVI with no PD and 392 with moderate PD. TAVI endpoints and adverse events were considered according to the Valve Academic Research Consortium (VARC)-2 definitions. Device success for the entire cohort was 95.1%. Post-dilatation was performed in nine patients in the no PD group (7.4%) and in 40 patients in the moderate PD group (10.2%) (p=0.06). Total fluoroscopy time and the amount of contrast used were lower in the no PD group. All-cause mortality up to 30 days was 3.3% in the no PD group vs. 3.6% in the moderate PD group (p=0.89). VARC-2 defined complication rates at 30 days including cerebrovascular accident (CVA)/transient ischaemic attack (TIA) were similar between groups. Overall, there was no significant difference in survival rates between the two groups (HR 1.33, 95% CI: 0.75-2.35; p=0.34).
CONCLUSIONS: Balloon-expandable TAVI with moderate or without balloon PD is feasible and safe. The omission of PD in appropriate cases was associated with reduced fluoroscopy time without affecting procedural success.
METHODS AND RESULTS: Overall, 121 patients underwent TAVI with no PD and 392 with moderate PD. TAVI endpoints and adverse events were considered according to the Valve Academic Research Consortium (VARC)-2 definitions. Device success for the entire cohort was 95.1%. Post-dilatation was performed in nine patients in the no PD group (7.4%) and in 40 patients in the moderate PD group (10.2%) (p=0.06). Total fluoroscopy time and the amount of contrast used were lower in the no PD group. All-cause mortality up to 30 days was 3.3% in the no PD group vs. 3.6% in the moderate PD group (p=0.89). VARC-2 defined complication rates at 30 days including cerebrovascular accident (CVA)/transient ischaemic attack (TIA) were similar between groups. Overall, there was no significant difference in survival rates between the two groups (HR 1.33, 95% CI: 0.75-2.35; p=0.34).
CONCLUSIONS: Balloon-expandable TAVI with moderate or without balloon PD is feasible and safe. The omission of PD in appropriate cases was associated with reduced fluoroscopy time without affecting procedural success.