Safety and efficacy of valve repositioning during transcatheter aortic valve replacement with the Lotus Valve System

Hashrul N.Z. Rashid, Robert Gooley, Liam McCormick, Sarah Zaman, Satish Ramkumar, Damon Jackson, Ameera Amiruddin, Arthur Nasis, James Cameron, Ian T. Meredith

Research output: Contribution to journalArticleResearchpeer-review

5 Citations (Scopus)

Abstract

Objective To determine the safety and efficacy of valve repositioning following transcatheter aortic valve replacement (TAVR) with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). Introduction TAVR is a well-established treatment for severe aortic stenosis. The Lotus Valve System is fully repositionable and retrievable. Valve repositioning has the potential to minimize TAVR-related complications caused by valve malposition; however, the effect on adverse event rates such as stroke is unknown. Methods Consecutive patients with severe aortic stenosis treated with the Lotus Valve System (n = 125) were prospectively recruited. Patients who did not require valve repositioning (Group A) were compared to patients who required one or more valve repositions (Group B). The primary end-point was 30-day occurrence of major adverse cardiovascular and cerebrovascular events (MACCE). Secondary end-points included each component of the primary end-point, new pacemaker insertion, and procedural or 30-day major adverse events, defined according to VARC-2 definitions. Results Valve repositioning was utilized in 60.8% (76/125) of patients including 17.1% (13/76) who required full valve resheathing. The most frequent indications for valve repositioning were altering the depth and angulation of initial implantation (69.7%), reducing paravalvular regurgitation (13.2%), and attempt to correct new or worsened heart block (7.9%). Baseline characteristics were similar in both groups. The primary end-point occurred in 12.2% and 6.6% of Group A and B, respectively (p = 0.10). Thirty-day new pacemaker implantation was 34.1% and 18.8% in Group A and B, respectively (p = 0.06). The secondary end-point measures were not significantly different between the groups. Conclusion Repositioning facilitated correct anatomical positioning of all devices leading to optimal prosthesis hemodynamics and a trend to lower pacemaker rate without increased risk of MACCE.

Original languageEnglish
Pages (from-to)55-61
Number of pages7
JournalJournal of Cardiology
Volume70
Issue number1
DOIs
Publication statusPublished - 1 Jul 2017

Keywords

  • Aortic stenosis
  • Lotus valve
  • Transcatheter aortic valve
  • Transcatheter aortic valve replacement

Cite this

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title = "Safety and efficacy of valve repositioning during transcatheter aortic valve replacement with the Lotus Valve System",
abstract = "Objective To determine the safety and efficacy of valve repositioning following transcatheter aortic valve replacement (TAVR) with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). Introduction TAVR is a well-established treatment for severe aortic stenosis. The Lotus Valve System is fully repositionable and retrievable. Valve repositioning has the potential to minimize TAVR-related complications caused by valve malposition; however, the effect on adverse event rates such as stroke is unknown. Methods Consecutive patients with severe aortic stenosis treated with the Lotus Valve System (n = 125) were prospectively recruited. Patients who did not require valve repositioning (Group A) were compared to patients who required one or more valve repositions (Group B). The primary end-point was 30-day occurrence of major adverse cardiovascular and cerebrovascular events (MACCE). Secondary end-points included each component of the primary end-point, new pacemaker insertion, and procedural or 30-day major adverse events, defined according to VARC-2 definitions. Results Valve repositioning was utilized in 60.8{\%} (76/125) of patients including 17.1{\%} (13/76) who required full valve resheathing. The most frequent indications for valve repositioning were altering the depth and angulation of initial implantation (69.7{\%}), reducing paravalvular regurgitation (13.2{\%}), and attempt to correct new or worsened heart block (7.9{\%}). Baseline characteristics were similar in both groups. The primary end-point occurred in 12.2{\%} and 6.6{\%} of Group A and B, respectively (p = 0.10). Thirty-day new pacemaker implantation was 34.1{\%} and 18.8{\%} in Group A and B, respectively (p = 0.06). The secondary end-point measures were not significantly different between the groups. Conclusion Repositioning facilitated correct anatomical positioning of all devices leading to optimal prosthesis hemodynamics and a trend to lower pacemaker rate without increased risk of MACCE.",
keywords = "Aortic stenosis, Lotus valve, Transcatheter aortic valve, Transcatheter aortic valve replacement",
author = "Rashid, {Hashrul N.Z.} and Robert Gooley and Liam McCormick and Sarah Zaman and Satish Ramkumar and Damon Jackson and Ameera Amiruddin and Arthur Nasis and James Cameron and Meredith, {Ian T.}",
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Safety and efficacy of valve repositioning during transcatheter aortic valve replacement with the Lotus Valve System. / Rashid, Hashrul N.Z.; Gooley, Robert; McCormick, Liam; Zaman, Sarah; Ramkumar, Satish; Jackson, Damon; Amiruddin, Ameera; Nasis, Arthur; Cameron, James; Meredith, Ian T.

In: Journal of Cardiology, Vol. 70, No. 1, 01.07.2017, p. 55-61.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Safety and efficacy of valve repositioning during transcatheter aortic valve replacement with the Lotus Valve System

AU - Rashid, Hashrul N.Z.

AU - Gooley, Robert

AU - McCormick, Liam

AU - Zaman, Sarah

AU - Ramkumar, Satish

AU - Jackson, Damon

AU - Amiruddin, Ameera

AU - Nasis, Arthur

AU - Cameron, James

AU - Meredith, Ian T.

PY - 2017/7/1

Y1 - 2017/7/1

N2 - Objective To determine the safety and efficacy of valve repositioning following transcatheter aortic valve replacement (TAVR) with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). Introduction TAVR is a well-established treatment for severe aortic stenosis. The Lotus Valve System is fully repositionable and retrievable. Valve repositioning has the potential to minimize TAVR-related complications caused by valve malposition; however, the effect on adverse event rates such as stroke is unknown. Methods Consecutive patients with severe aortic stenosis treated with the Lotus Valve System (n = 125) were prospectively recruited. Patients who did not require valve repositioning (Group A) were compared to patients who required one or more valve repositions (Group B). The primary end-point was 30-day occurrence of major adverse cardiovascular and cerebrovascular events (MACCE). Secondary end-points included each component of the primary end-point, new pacemaker insertion, and procedural or 30-day major adverse events, defined according to VARC-2 definitions. Results Valve repositioning was utilized in 60.8% (76/125) of patients including 17.1% (13/76) who required full valve resheathing. The most frequent indications for valve repositioning were altering the depth and angulation of initial implantation (69.7%), reducing paravalvular regurgitation (13.2%), and attempt to correct new or worsened heart block (7.9%). Baseline characteristics were similar in both groups. The primary end-point occurred in 12.2% and 6.6% of Group A and B, respectively (p = 0.10). Thirty-day new pacemaker implantation was 34.1% and 18.8% in Group A and B, respectively (p = 0.06). The secondary end-point measures were not significantly different between the groups. Conclusion Repositioning facilitated correct anatomical positioning of all devices leading to optimal prosthesis hemodynamics and a trend to lower pacemaker rate without increased risk of MACCE.

AB - Objective To determine the safety and efficacy of valve repositioning following transcatheter aortic valve replacement (TAVR) with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). Introduction TAVR is a well-established treatment for severe aortic stenosis. The Lotus Valve System is fully repositionable and retrievable. Valve repositioning has the potential to minimize TAVR-related complications caused by valve malposition; however, the effect on adverse event rates such as stroke is unknown. Methods Consecutive patients with severe aortic stenosis treated with the Lotus Valve System (n = 125) were prospectively recruited. Patients who did not require valve repositioning (Group A) were compared to patients who required one or more valve repositions (Group B). The primary end-point was 30-day occurrence of major adverse cardiovascular and cerebrovascular events (MACCE). Secondary end-points included each component of the primary end-point, new pacemaker insertion, and procedural or 30-day major adverse events, defined according to VARC-2 definitions. Results Valve repositioning was utilized in 60.8% (76/125) of patients including 17.1% (13/76) who required full valve resheathing. The most frequent indications for valve repositioning were altering the depth and angulation of initial implantation (69.7%), reducing paravalvular regurgitation (13.2%), and attempt to correct new or worsened heart block (7.9%). Baseline characteristics were similar in both groups. The primary end-point occurred in 12.2% and 6.6% of Group A and B, respectively (p = 0.10). Thirty-day new pacemaker implantation was 34.1% and 18.8% in Group A and B, respectively (p = 0.06). The secondary end-point measures were not significantly different between the groups. Conclusion Repositioning facilitated correct anatomical positioning of all devices leading to optimal prosthesis hemodynamics and a trend to lower pacemaker rate without increased risk of MACCE.

KW - Aortic stenosis

KW - Lotus valve

KW - Transcatheter aortic valve

KW - Transcatheter aortic valve replacement

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U2 - 10.1016/j.jjcc.2016.11.002

DO - 10.1016/j.jjcc.2016.11.002

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JO - Journal of Cardiology

JF - Journal of Cardiology

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