TY - JOUR
T1 - The Novel FlexNav Delivery System for Transcatheter Aortic Valve Implantation With the Portico Device
T2 - A Case Series
AU - Corcione, Nicola
AU - Morello, Alberto
AU - Ferraro, Paolo
AU - Cimmino, Michele
AU - Albanese, Michele
AU - Ausiello, Arturo
AU - Pepe, Martino
AU - Biondi-Zoccai, Giuseppe
AU - Giordano, Arturo
PY - 2021/6/1
Y1 - 2021/6/1
N2 - BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a safe and beneficial treatment for patients with severe symptomatic aortic stenosis at high and intermediate surgical risk. Success rates for TAVI continue to increase due to more refined procedural approaches and devices, and above all, to the improvements in procedural knowledge by TAVI operators. The development of a new delivery system represents an important evolutionary process in the TAVI procedure, both for the type of device and for the operators, as it may substantially expand indications, success rates, and safety. FlexNav (Abbott Cardiovascular) is a novel delivery system designed to improve ease and precision of TAVI using the Abbott Portico valve. Despite limited results on its advantages, such as those provided in the PORTICO investigational device exemption substudy, uncertainty persists on the actual role of FlexNav in real-world practice. METHODS AND RESULTS: We hereby present our preliminary experience with FlexNav in a consecutive series of 18 patients undergoing TAVI with Portico valve in early 2020 (3 with axillary access). Procedural results were excellent, as shown by the absence of deaths, strokes, and major vascular complications (95% confidence interval, 0%-18.5%), and pacemaker implantation in 3 subjects (21.4%; 95% confidence interval, 4.7%-50.8%). CONCLUSIONS: Despite the small sample size, the present case series suggests that adoption of the FlexNav novel delivery system for TAVI with Portico valve is feasible and safe, and holds the promise of further improving early and long-term results of this procedure.
AB - BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a safe and beneficial treatment for patients with severe symptomatic aortic stenosis at high and intermediate surgical risk. Success rates for TAVI continue to increase due to more refined procedural approaches and devices, and above all, to the improvements in procedural knowledge by TAVI operators. The development of a new delivery system represents an important evolutionary process in the TAVI procedure, both for the type of device and for the operators, as it may substantially expand indications, success rates, and safety. FlexNav (Abbott Cardiovascular) is a novel delivery system designed to improve ease and precision of TAVI using the Abbott Portico valve. Despite limited results on its advantages, such as those provided in the PORTICO investigational device exemption substudy, uncertainty persists on the actual role of FlexNav in real-world practice. METHODS AND RESULTS: We hereby present our preliminary experience with FlexNav in a consecutive series of 18 patients undergoing TAVI with Portico valve in early 2020 (3 with axillary access). Procedural results were excellent, as shown by the absence of deaths, strokes, and major vascular complications (95% confidence interval, 0%-18.5%), and pacemaker implantation in 3 subjects (21.4%; 95% confidence interval, 4.7%-50.8%). CONCLUSIONS: Despite the small sample size, the present case series suggests that adoption of the FlexNav novel delivery system for TAVI with Portico valve is feasible and safe, and holds the promise of further improving early and long-term results of this procedure.
KW - aortic stenosis
KW - delivery system
KW - FlexNav
KW - Portico valve
KW - transcatheter aortic valve implantation
UR - http://www.scopus.com/inward/record.url?scp=85107902318&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85107902318&partnerID=8YFLogxK
M3 - Article
C2 - 34001674
AN - SCOPUS:85107902318
VL - 33
SP - E474-E478
JO - Journal of Invasive Cardiology
JF - Journal of Invasive Cardiology
SN - 1042-3931
IS - 6
ER -