TY - JOUR
T1 - Current Generation Balloon-Expandable Transcatheter Valve Positioning Strategies During Aortic Valve-in-Valve Procedures and Clinical Outcomes
AU - Simonato, Matheus
AU - Webb, John
AU - Bleiziffer, Sabine
AU - Abdel-Wahab, Mohamed
AU - Wood, D.
AU - Seiffert, Moritz
AU - Schäfer, Ulrich
AU - Wöhrle, Jochen
AU - Jochheim, D.
AU - Woitek, F.
AU - Latib, A.
AU - Barbanti, M.
AU - Spargias, Konstantinos
AU - Kodali, Susheel
AU - Jones, Tara
AU - Tchetche, Didier
AU - Coutinho, Rafael
AU - Napodano, Massimo
AU - Garcia, Santiago
AU - Veulemans, Verena
AU - Siqueira, Dimytri
AU - Windecker, Stephan
AU - Cerillo, Alfredo
AU - Kempfert, Jörg
AU - Agrifoglio, M.
AU - Bonaros, Nikolaos
AU - Schoels, Wolfgang
AU - Baumbach, H.
AU - Schofer, Joachim
AU - Gaia, Diego Felipe
AU - Dvir, D.
N1 - Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/8/26
Y1 - 2019/8/26
N2 - Objectives: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. Background: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. Methods: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%. Results: A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. Conclusions: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.
AB - Objectives: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. Background: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. Methods: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%. Results: A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. Conclusions: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.
KW - aortic valve-in-valve
KW - balloon-expandable valve
KW - elevated gradients
KW - pacemaker
UR - http://www.scopus.com/inward/record.url?scp=85070395395&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85070395395&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2019.05.057
DO - 10.1016/j.jcin.2019.05.057
M3 - Article
C2 - 31439340
AN - SCOPUS:85070395395
SN - 1936-8798
VL - 12
SP - 1606
EP - 1617
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 16
ER -