Current Generation Balloon-Expandable Transcatheter Valve Positioning Strategies During Aortic Valve-in-Valve Procedures and Clinical Outcomes

Matheus Simonato, John Webb, Sabine Bleiziffer, Mohamed Abdel-Wahab, David Wood, Moritz Seiffert, Ulrich Schäfer, Jochen Wöhrle, David Jochheim, Felix Woitek, Azeem Latib, Marco Barbanti, Konstantinos Spargias, Susheel Kodali, Tara Jones, Didier Tchetche, Rafael Coutinho, Massimo Napodano, Santiago Garcia, Verena VeulemansDimytri Siqueira, Stephan Windecker, Alfredo Cerillo, Jörg Kempfert, Marco Agrifoglio, Nikolaos Bonaros, Wolfgang Schoels, Hardy Baumbach, Joachim Schofer, Diego Felipe Gaia, Danny Dvir

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)1606-1617
Number of pages12
JournalJACC: Cardiovascular Interventions
Volume12
Issue number16
DOIs
Publication statusPublished - Aug 26 2019

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