Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis

Susheel Kodali*, Vinod H. Thourani, Jonathon White, S Chris Malaisrie, Scott Lim, Kevin L. Greason, Mathew Williams, Mayra Guerrero, Andrew C. Eisenhauer, Samir Kapadia, Dean J. Kereiakes, Howard C. Herrmann, Vasilis Babaliaros, Wilson Y. Szeto, Rebecca T. Hahn, Philippe Pibarot, Neil J. Weissman, Jonathon Leipsic, Philipp Blanke, Brian K. WhisenantRakesh M. Suri, Raj R. Makkar, Girma M. Ayele, Lars G. Svensson, John G. Webb, Michael J. Mack, Craig R. Smith, Martin B. Leon

*Corresponding author for this work

Research output: Contribution to journalArticle

181 Citations (Scopus)

Abstract

Aims Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV). Methods and results Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm2. Conclusions The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation. Trial Registration ClinicalTrials.gov #NCT01314313.

Original languageEnglish (US)
Pages (from-to)2252-2262
Number of pages11
JournalEuropean Heart Journal
Volume37
Issue number28
DOIs
StatePublished - Jul 21 2016

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Aortic Valve Stenosis
Stroke
Heart Valves
Blood Vessels
Registries
Mortality
Transcatheter Aortic Valve Replacement
Hemorrhage
Equipment and Supplies
Cardiomyopathies
Aortic Valve
Canada
Thorax

Keywords

  • TAVI
  • TAVR
  • Transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Kodali, Susheel ; Thourani, Vinod H. ; White, Jonathon ; Malaisrie, S Chris ; Lim, Scott ; Greason, Kevin L. ; Williams, Mathew ; Guerrero, Mayra ; Eisenhauer, Andrew C. ; Kapadia, Samir ; Kereiakes, Dean J. ; Herrmann, Howard C. ; Babaliaros, Vasilis ; Szeto, Wilson Y. ; Hahn, Rebecca T. ; Pibarot, Philippe ; Weissman, Neil J. ; Leipsic, Jonathon ; Blanke, Philipp ; Whisenant, Brian K. ; Suri, Rakesh M. ; Makkar, Raj R. ; Ayele, Girma M. ; Svensson, Lars G. ; Webb, John G. ; Mack, Michael J. ; Smith, Craig R. ; Leon, Martin B. / Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. In: European Heart Journal. 2016 ; Vol. 37, No. 28. pp. 2252-2262.
@article{3c2406b7c4c341f2a125ceca779fe351,
title = "Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis",
abstract = "Aims Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV). Methods and results Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9{\%}) and transapical or transaortic (n = 218, 13.1{\%}) access routes. The rate of 30-day all-cause mortality was 2.2{\%} in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7{\%}] and 1.1{\%} in IR patients (mean STS score 5.3{\%}); cardiovascular mortality was 1.4 and 0.9{\%}, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9{\%}, major bleeding 14.0{\%}, major vascular complications 5.1{\%}, and requirement for permanent pacemaker 13.3{\%}. In IR patients, the 30-day rate of major/disabling stroke was 1.0{\%}, major bleeding 10.6{\%}, major vascular complications 6.1{\%}, and requirement for permanent pacemaker 10.1{\%}. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9{\%} of patients, mild in 40.7{\%}, moderate in 3.4{\%}, and severe in 0.0{\%}. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm2. Conclusions The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation. Trial Registration ClinicalTrials.gov #NCT01314313.",
keywords = "TAVI, TAVR, Transcatheter aortic valve replacement",
author = "Susheel Kodali and Thourani, {Vinod H.} and Jonathon White and Malaisrie, {S Chris} and Scott Lim and Greason, {Kevin L.} and Mathew Williams and Mayra Guerrero and Eisenhauer, {Andrew C.} and Samir Kapadia and Kereiakes, {Dean J.} and Herrmann, {Howard C.} and Vasilis Babaliaros and Szeto, {Wilson Y.} and Hahn, {Rebecca T.} and Philippe Pibarot and Weissman, {Neil J.} and Jonathon Leipsic and Philipp Blanke and Whisenant, {Brian K.} and Suri, {Rakesh M.} and Makkar, {Raj R.} and Ayele, {Girma M.} and Svensson, {Lars G.} and Webb, {John G.} and Mack, {Michael J.} and Smith, {Craig R.} and Leon, {Martin B.}",
year = "2016",
month = "7",
day = "21",
doi = "10.1093/eurheartj/ehw112",
language = "English (US)",
volume = "37",
pages = "2252--2262",
journal = "European Heart Journal",
issn = "0195-668X",
publisher = "Oxford University Press",
number = "28",

}

Kodali, S, Thourani, VH, White, J, Malaisrie, SC, Lim, S, Greason, KL, Williams, M, Guerrero, M, Eisenhauer, AC, Kapadia, S, Kereiakes, DJ, Herrmann, HC, Babaliaros, V, Szeto, WY, Hahn, RT, Pibarot, P, Weissman, NJ, Leipsic, J, Blanke, P, Whisenant, BK, Suri, RM, Makkar, RR, Ayele, GM, Svensson, LG, Webb, JG, Mack, MJ, Smith, CR & Leon, MB 2016, 'Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis', European Heart Journal, vol. 37, no. 28, pp. 2252-2262. https://doi.org/10.1093/eurheartj/ehw112

Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. / Kodali, Susheel; Thourani, Vinod H.; White, Jonathon; Malaisrie, S Chris; Lim, Scott; Greason, Kevin L.; Williams, Mathew; Guerrero, Mayra; Eisenhauer, Andrew C.; Kapadia, Samir; Kereiakes, Dean J.; Herrmann, Howard C.; Babaliaros, Vasilis; Szeto, Wilson Y.; Hahn, Rebecca T.; Pibarot, Philippe; Weissman, Neil J.; Leipsic, Jonathon; Blanke, Philipp; Whisenant, Brian K.; Suri, Rakesh M.; Makkar, Raj R.; Ayele, Girma M.; Svensson, Lars G.; Webb, John G.; Mack, Michael J.; Smith, Craig R.; Leon, Martin B.

In: European Heart Journal, Vol. 37, No. 28, 21.07.2016, p. 2252-2262.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis

AU - Kodali, Susheel

AU - Thourani, Vinod H.

AU - White, Jonathon

AU - Malaisrie, S Chris

AU - Lim, Scott

AU - Greason, Kevin L.

AU - Williams, Mathew

AU - Guerrero, Mayra

AU - Eisenhauer, Andrew C.

AU - Kapadia, Samir

AU - Kereiakes, Dean J.

AU - Herrmann, Howard C.

AU - Babaliaros, Vasilis

AU - Szeto, Wilson Y.

AU - Hahn, Rebecca T.

AU - Pibarot, Philippe

AU - Weissman, Neil J.

AU - Leipsic, Jonathon

AU - Blanke, Philipp

AU - Whisenant, Brian K.

AU - Suri, Rakesh M.

AU - Makkar, Raj R.

AU - Ayele, Girma M.

AU - Svensson, Lars G.

AU - Webb, John G.

AU - Mack, Michael J.

AU - Smith, Craig R.

AU - Leon, Martin B.

PY - 2016/7/21

Y1 - 2016/7/21

N2 - Aims Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV). Methods and results Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm2. Conclusions The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation. Trial Registration ClinicalTrials.gov #NCT01314313.

AB - Aims Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV). Methods and results Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm2. Conclusions The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation. Trial Registration ClinicalTrials.gov #NCT01314313.

KW - TAVI

KW - TAVR

KW - Transcatheter aortic valve replacement

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U2 - 10.1093/eurheartj/ehw112

DO - 10.1093/eurheartj/ehw112

M3 - Article

C2 - 27190101

AN - SCOPUS:84991625019

VL - 37

SP - 2252

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JO - European Heart Journal

JF - European Heart Journal

SN - 0195-668X

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