Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve

Aditya Sengupta; Syed Zaid; Norihiko Kamioka; Juan Terre; Masaki Miyasaka; Sameer A. Hirji; Mark Hensey; Nadim Geloo; George Petrossian; Newell Robinson; Eric Sarin; Liam Ryan; Sung Han Yoon; Christina W. Tan; Omar K. Khalique; Susheel K. Kodali; Tsuyoshi Kaneko; Pinak B. Shah; S. Chiu Wong; Arash Salemi; Kapil Sharma; Joseph A. Kozina; Molly A. Szerlip; Creighton W. Don; Sameer Gafoor; Ming Zhang; Zachary Newhart; Samir R. Kapadia; Stephanie L. Mick; Amar Krishnaswamy; Annapoorna Kini; Hasan Ahmad; Steven L. Lansman; Michael J. Mack; John G. Webb; Vasilis Babaliaros; Vinod H. Thourani; Raj R. Makkar; Martin B. Leon; Isaac George; Gilbert H.L. Tang

doi:10.1016/j.jcin.2019.08.042

Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve

Aditya Sengupta, Syed Zaid, Norihiko Kamioka, Juan Terre, Masaki Miyasaka, Sameer A. Hirji, Mark Hensey, Nadim Geloo, George Petrossian, Newell Robinson, Eric Sarin, Liam Ryan, Sung Han Yoon, Christina W. Tan, Omar K. Khalique, Susheel K. Kodali, Tsuyoshi Kaneko, Pinak B. Shah, S. Chiu Wong, Arash SalemiKapil Sharma, Joseph A. Kozina, Molly A. Szerlip, Creighton W. Don, Sameer Gafoor, Ming Zhang, Zachary Newhart, Samir R. Kapadia, Stephanie L. Mick, Amar Krishnaswamy, Annapoorna Kini, Hasan Ahmad, Steven L. Lansman, Michael J. Mack, John G. Webb, Vasilis Babaliaros, Vinod H. Thourani, Raj R. Makkar, Martin B. Leon, Isaac George, Gilbert H.L. Tang

Research output: Contribution to journal › Article › peer-review

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Abstract

Objectives: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm² have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. Methods: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm² (range 683.5 to 852.0 mm²) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. Results: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. Conclusions: S3 TAVR in annular areas >683 mm² is feasible, with favorable mid-term outcomes.

Original language	English
Pages (from-to)	210-216
Number of pages	7
Journal	JACC: Cardiovascular Interventions
Volume	13
Issue number	2
DOIs	https://doi.org/10.1016/j.jcin.2019.08.042
State	Published - Jan 27 2020

Keywords

TAVR
aortic stenosis
aortic valve
large annuli
paravalvular leak

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10.1016/j.jcin.2019.08.042

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Sengupta, A., Zaid, S., Kamioka, N., Terre, J., Miyasaka, M., Hirji, S. A., Hensey, M., Geloo, N., Petrossian, G., Robinson, N., Sarin, E., Ryan, L., Yoon, S. H., Tan, C. W., Khalique, O. K., Kodali, S. K., Kaneko, T., Shah, P. B., Wong, S. C., ... Tang, G. H. L. (2020). Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve. JACC: Cardiovascular Interventions, 13(2), 210-216. https://doi.org/10.1016/j.jcin.2019.08.042

@article{8a875a0e534544528443fc683ff0df75,

title = "Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve",

abstract = "Objectives: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. Methods: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. Results: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. Conclusions: S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.",

keywords = "TAVR, aortic stenosis, aortic valve, large annuli, paravalvular leak",

author = "Aditya Sengupta and Syed Zaid and Norihiko Kamioka and Juan Terre and Masaki Miyasaka and Hirji, {Sameer A.} and Mark Hensey and Nadim Geloo and George Petrossian and Newell Robinson and Eric Sarin and Liam Ryan and Yoon, {Sung Han} and Tan, {Christina W.} and Khalique, {Omar K.} and Kodali, {Susheel K.} and Tsuyoshi Kaneko and Shah, {Pinak B.} and Wong, {S. Chiu} and Arash Salemi and Kapil Sharma and Kozina, {Joseph A.} and Szerlip, {Molly A.} and Don, {Creighton W.} and Sameer Gafoor and Ming Zhang and Zachary Newhart and Kapadia, {Samir R.} and Mick, {Stephanie L.} and Amar Krishnaswamy and Annapoorna Kini and Hasan Ahmad and Lansman, {Steven L.} and Mack, {Michael J.} and Webb, {John G.} and Vasilis Babaliaros and Thourani, {Vinod H.} and Makkar, {Raj R.} and Leon, {Martin B.} and Isaac George and Tang, {Gilbert H.L.}",

note = "Publisher Copyright: {\textcopyright} 2020 American College of Cardiology Foundation",

year = "2020",

month = jan,

day = "27",

doi = "10.1016/j.jcin.2019.08.042",

language = "English",

volume = "13",

pages = "210--216",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

number = "2",

}

Sengupta, A, Zaid, S, Kamioka, N, Terre, J, Miyasaka, M, Hirji, SA, Hensey, M, Geloo, N, Petrossian, G, Robinson, N, Sarin, E, Ryan, L, Yoon, SH, Tan, CW, Khalique, OK, Kodali, SK, Kaneko, T, Shah, PB, Wong, SC, Salemi, A, Sharma, K, Kozina, JA, Szerlip, MA, Don, CW, Gafoor, S, Zhang, M, Newhart, Z, Kapadia, SR, Mick, SL, Krishnaswamy, A, Kini, A, Ahmad, H, Lansman, SL, Mack, MJ, Webb, JG, Babaliaros, V, Thourani, VH, Makkar, RR, Leon, MB, George, I & Tang, GHL 2020, 'Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve', JACC: Cardiovascular Interventions, vol. 13, no. 2, pp. 210-216. https://doi.org/10.1016/j.jcin.2019.08.042

TY - JOUR

T1 - Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve

AU - Sengupta, Aditya

AU - Zaid, Syed

AU - Kamioka, Norihiko

AU - Terre, Juan

AU - Miyasaka, Masaki

AU - Hirji, Sameer A.

AU - Hensey, Mark

AU - Geloo, Nadim

AU - Petrossian, George

AU - Robinson, Newell

AU - Sarin, Eric

AU - Ryan, Liam

AU - Yoon, Sung Han

AU - Tan, Christina W.

AU - Khalique, Omar K.

AU - Kodali, Susheel K.

AU - Kaneko, Tsuyoshi

AU - Shah, Pinak B.

AU - Wong, S. Chiu

AU - Salemi, Arash

AU - Sharma, Kapil

AU - Kozina, Joseph A.

AU - Szerlip, Molly A.

AU - Don, Creighton W.

AU - Gafoor, Sameer

AU - Zhang, Ming

AU - Newhart, Zachary

AU - Kapadia, Samir R.

AU - Mick, Stephanie L.

AU - Krishnaswamy, Amar

AU - Kini, Annapoorna

AU - Ahmad, Hasan

AU - Lansman, Steven L.

AU - Mack, Michael J.

AU - Webb, John G.

AU - Babaliaros, Vasilis

AU - Thourani, Vinod H.

AU - Makkar, Raj R.

AU - Leon, Martin B.

AU - George, Isaac

AU - Tang, Gilbert H.L.

PY - 2020/1/27

Y1 - 2020/1/27

N2 - Objectives: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. Methods: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. Results: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. Conclusions: S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.

AB - Objectives: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. Methods: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. Results: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. Conclusions: S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.

KW - TAVR

KW - aortic stenosis

KW - aortic valve

KW - large annuli

KW - paravalvular leak

UR - http://www.scopus.com/inward/record.url?scp=85077656723&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2019.08.042

DO - 10.1016/j.jcin.2019.08.042

M3 - Article

C2 - 31883715

AN - SCOPUS:85077656723

SN - 1936-8798

VL - 13

SP - 210

EP - 216

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 2

ER -

Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve

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