Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve: Results of the RELEVANT study

RA Montone, L Testa, C Fraccaro, M Montorfano, F Castriota, R Nerla, M Angelillis, M Tusa, Francesco Giannini, A Garatti, Giuseppe Tarantini, A Sonia Petronio, N Brambilla, F Bedogni

Research output: Contribution to journalArticle

Abstract

Objectives: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population. Background: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry. Methods: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria. Results: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6±6.3 years, 51.6% females. Mean STS score for mortality was 8.3±5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR. Conclusions: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc.
Original languageEnglish
Pages (from-to)1206-1211
Number of pages6
JournalCatheterization and Cardiovascular Interventions
Volume90
Issue number7
DOIs
Publication statusPublished - 2017

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Aortic Valve Stenosis
Registries
Mortality
Safety
Equipment and Supplies
Patient Discharge
Transcatheter Aortic Valve Replacement
Research
Population
Stroke
Therapeutics

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Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve: Results of the RELEVANT study. / Montone, RA; Testa, L; Fraccaro, C; Montorfano, M; Castriota, F; Nerla, R; Angelillis, M; Tusa, M; Giannini, Francesco; Garatti, A; Tarantini, Giuseppe; Sonia Petronio, A; Brambilla, N; Bedogni, F.

In: Catheterization and Cardiovascular Interventions, Vol. 90, No. 7, 2017, p. 1206-1211.

Research output: Contribution to journalArticle

Montone, RA ; Testa, L ; Fraccaro, C ; Montorfano, M ; Castriota, F ; Nerla, R ; Angelillis, M ; Tusa, M ; Giannini, Francesco ; Garatti, A ; Tarantini, Giuseppe ; Sonia Petronio, A ; Brambilla, N ; Bedogni, F. / Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve: Results of the RELEVANT study. In: Catheterization and Cardiovascular Interventions. 2017 ; Vol. 90, No. 7. pp. 1206-1211.
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abstract = "Objectives: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population. Background: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry. Methods: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria. Results: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6±6.3 years, 51.6{\%} females. Mean STS score for mortality was 8.3±5.6. Procedural success was achieved in 98.7{\%} of patients. All-cause mortality was 2.2{\%} at discharge and 2.7{\%} at 30-day. Stroke rate was 2.2{\%} at discharge and 3.1{\%} at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7{\%} at discharge and 31.8{\%} at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1{\%} of patients at discharge. Only two patients (0.9{\%}) had moderate PVR at discharge and at 30-day, whereas none had severe PVR. Conclusions: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. {\circledC} 2017 Wiley Periodicals, Inc.",
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T1 - Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve: Results of the RELEVANT study

AU - Montone, RA

AU - Testa, L

AU - Fraccaro, C

AU - Montorfano, M

AU - Castriota, F

AU - Nerla, R

AU - Angelillis, M

AU - Tusa, M

AU - Giannini, Francesco

AU - Garatti, A

AU - Tarantini, Giuseppe

AU - Sonia Petronio, A

AU - Brambilla, N

AU - Bedogni, F

PY - 2017

Y1 - 2017

N2 - Objectives: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population. Background: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry. Methods: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria. Results: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6±6.3 years, 51.6% females. Mean STS score for mortality was 8.3±5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR. Conclusions: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc.

AB - Objectives: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population. Background: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry. Methods: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria. Results: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6±6.3 years, 51.6% females. Mean STS score for mortality was 8.3±5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR. Conclusions: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc.

U2 - 10.1002/ccd.26914

DO - 10.1002/ccd.26914

M3 - Article

VL - 90

SP - 1206

EP - 1211

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

IS - 7

ER -