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

Rocco A. Montone, Luca Testa, Chiara Fraccaro, Matteo Montorfano, Fausto Castriota, Roberto Nerla, Marco Angelillis, Maurizio Tusa, Francesco Giannini, Andrea Garatti, Giuseppe Tarantini, Anna Sonia Petronio, Nedy Brambilla, Francesco 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.

Original languageEnglish
Pages (from-to)1206-1211
Number of pages6
JournalCatheterization and Cardiovascular Interventions
Volume90
Issue number7
DOIs
Publication statusPublished - Dec 1 2017

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

Keywords

  • aortic valve disease
  • percutaneous intervention
  • structural heart disease intervention
  • transcatheter valve implantation

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve : Results of the RELEVANT study. / Montone, Rocco A.; Testa, Luca; Fraccaro, Chiara; Montorfano, Matteo; Castriota, Fausto; Nerla, Roberto; Angelillis, Marco; Tusa, Maurizio; Giannini, Francesco; Garatti, Andrea; Tarantini, Giuseppe; Petronio, Anna Sonia; Brambilla, Nedy; Bedogni, Francesco.

In: Catheterization and Cardiovascular Interventions, Vol. 90, No. 7, 01.12.2017, p. 1206-1211.

Research output: Contribution to journalArticle

Montone, Rocco A. ; Testa, Luca ; Fraccaro, Chiara ; Montorfano, Matteo ; Castriota, Fausto ; Nerla, Roberto ; Angelillis, Marco ; Tusa, Maurizio ; Giannini, Francesco ; Garatti, Andrea ; Tarantini, Giuseppe ; Petronio, Anna Sonia ; Brambilla, Nedy ; Bedogni, Francesco. / 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.",
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T2 - Results of the RELEVANT study

AU - Montone, Rocco A.

AU - Testa, Luca

AU - Fraccaro, Chiara

AU - Montorfano, Matteo

AU - Castriota, Fausto

AU - Nerla, Roberto

AU - Angelillis, Marco

AU - Tusa, Maurizio

AU - Giannini, Francesco

AU - Garatti, Andrea

AU - Tarantini, Giuseppe

AU - Petronio, Anna Sonia

AU - Brambilla, Nedy

AU - Bedogni, Francesco

PY - 2017/12/1

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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.

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.

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KW - structural heart disease intervention

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