First‐in‐man transfemoral transcatheter aortic valve replacement with the 29 mm Edwards SAPIEN XT Valve

Freeman, Mélanie; Rodés‐Cabau, Josep; Ureña, Marina; DeLarochellière, Robert; Dumont, Éric; Masson, Jean‐Bernard; Willson, Alexander B.; Binder, Ronald K.; Toggweiler, Stefan; Leipsic, Jonathon; Wood, David; Webb, John G.

doi:10.1002/ccd.24543

Cited by 11 publications

(8 citation statements)

References 19 publications

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“…The Sapien 3 introduced the 14 or 16Fr e-sheath with its dynamic expansion mechanism. 34 Binder et al compared the Sapien XT with Sapien 3 and showed a lower rate of major VC in Sapien 3 group. 12 With SEV there was a tendency toward fewer major VCs with Evolut R vs. Medtronic CoreValve studies (5.98% vs. 7.97%, p = 0.094).…”

Section: Discussionmentioning

confidence: 99%

Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis

Rahhab¹,

Misier²,

Faquir³

et al. 2020

Structural Heart

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Background: Vascular complications (VCs) after transcatheter aortic valve implantation (TAVI) are associated with impaired outcome. We performed a meta-analysis to determine in-hospital/30-day major VCs rate after transfemoral-TAVI adjudicated by an independent clinical-event-committee, and to compare the major VCs rate with regard to consecutive generations of balloonexpandable and self-expanding platforms, device profile, experience and patient risk-profile. Methods: A systematic, computerized search with predefined criteria was performed in PubMed, Embase and Cochrane on March 27, 2018. The overall pooled proportion of VC was calculated using a random-effects model. Subgroups were examined based on sheath size, STS-score and start-date of inclusion (early (< January 2012); late-phase (≥ January 2012) studies). Results: A total of 24 studies with 14308 patients were included. The pooled major VCs rate was 7.71% and was lower in lowprofile vs. high-profile device studies (5.51% vs. 8.46%, p = 0.0015). Major VCs rate decreased significantly with transition to newer generation balloon-expandable valves ((Sapien vs. Sapien XT (15.18% vs. 8.48%, p < 0.00001); Sapien XT vs. Sapien 3 (8.48% vs. 4.48%, p = 0.005)) and there was a tendency towards fewer major VCs in EvolutR vs. CoreValve (5.98% vs. 7.97%, p = 0.094). Major VC rate was lower in late-phase vs. early-phase studies (5.82% vs. 7.84%, p = 0.048) and a tendency towards a lower rate was seen in intermediate vs. high-risk studies (7.09% vs. 9.62%, p = 0.059). Conclusion: The pooled rate of independently adjudicated major VCs after transfemoral-TAVI was 7.71%. Experience and device profile are associated with fewer major VCs.

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Section: Discussionmentioning

confidence: 99%

Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis

Rahhab¹,

Misier²,

Faquir³

et al. 2020

Structural Heart

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“…The trauma of dilation during sheath insertion is greatly reduced. Immediately after the transcatheter heart valve passes, the sheath returns to a low profile diameter [39]. This reduces the time the access vessel is expanded, thereby hypothetically minimizing the risk of vascular trauma (Figure 7).…”

Section: Reviewmentioning

confidence: 98%

Interventions to reduce major vascular complications of TAVR

Barbanti

Webb

2013

Expert Review of Cardiovascular Therapy

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“…The SoloPath™ (Onset Medical, Terumo Medical Corporation, Irvine, CA, United States) is a balloon expandable transfemoral introducer; it has an inner diameter of 14-21 F (outer diameter 17-24 F) and is compatible with the 18 F Medtronic/CoreValve and the 23-and 26-mm Edward SAPIEN XT delivery system. Its peculiarity is represented by a 13.5 F distal part to facilitate vessel entry, that can be expanded by the integrated balloon inflation reaching its nominal diameter, after sheath insertion, and can be deflated at the end of the procedure, enabling low-resistance removal [32,33] . The SoloPath sheath is a feasible alternative to conventional sheaths for transfemoral TAVR patients with advanced atherosclerotic disease or an arterial diameter ≤ 7 mm [34] .…”

Section: Novel Vascular Sheaths For Transfemoral Tavimentioning

confidence: 99%

Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation

Dato

Burzotta

Trani

et al. 2014

WJC

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Transcatheter aortic valve implantation (TAVI) using stent-based bioprostheses has recently emerged as a promising alternative to surgical valve replacement in selected patients. The main route for TAVI is retrograde access from the femoral artery using large sheaths (16-24 F). Vascular access complications are a clinically relevant issue in TAVI procedures since they are reported to occur in up to one fourth of patients and are strongly associated with adverse outcomes. In the present paper, we review the different types of vascular access site complications associated with transfemoral TAVI. Moreover, we discuss the possible optimal management strategies with particular attention to the relevance of early diagnosis and prompt treatment using endovascular techniques.© 2014 Baishideng Publishing Group Inc. All rights reserved. Key words: Transfemoral transcatheter aortic valve implantation; Vascular access complication; Percutaneous managementCore tip: Vascular complications are not rare in transcatheter aortic valve implantation (TAVI) by the transfemoral approach and can significantly affect the overall clinical outcome. After diagnosis, the application of simple vascular interventional techniques allows efficient complication management, thus avoiding high risk vascular surgery. We discuss the available percutaneous vascular access preparation by dedicated devices, the principal diagnostic tools for prevention and detection of vascular complications and their percutaneous management in the transfemoral TAVI setting.Dato I, Burzotta F, Trani C, Crea F, Ussia GP. Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation.

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First‐in‐man transfemoral transcatheter aortic valve replacement with the 29 mm Edwards SAPIEN XT Valve

Abstract: Transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath was feasible with acceptable short-term outcomes.

Cited by 11 publications

References 19 publications

Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis

Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis

Interventions to reduce major vascular complications of TAVR

Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation

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