OBSERVANT II: Studio osservazionale per la valutazione di efficacia delle procedure transcatetere con dispositivi di nuova generazione nel trattamento della stenosi aortica sintomatica severa. Protocollo di studio

Translated title of the contribution: OBSERVANT II: Observational study of effectiveness of transcatheter aortic valve implantation with new generation devices for severe aortic stenosis treatment. Study protocol

Fulvia Seccareccia, Giuseppe Tarantini, Francesco Bedogni, Sergio Berti, Gennaro Santoro, Corrado Tamburino, Gian Paolo Ussia, Marco Barbanti, Massimo Baiocchi, Marco Ranucci, Paola D'Errigo, Stefano Rosato, Giuseppe Musumeci

Research output: Contribution to journalArticle

Abstract

Background. The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study. Methods. OBSERVANT II is an observational multicenter, prospective, cohort study collecting data on patients with severe symptomatic aortic stenosis undergoing TAVI in Italian hospitals since December 15, 2016, for at least 12 months. For each patient, data on demographic characteristics, health status, type of intervention and presence of comorbidities will be collected. Mortality and incidence of in-hospital major adverse cardiac and cerebrovascular events (MACCE) within 36 months of intervention will be the primary adverse outcome. Secondary outcomes will include 30-day mortality and the incidence of MACCE at 12 and 24 months. The statistical hypotheses were formulated considering the results from the OBSERVANT study. Testing these hypotheses will require the recruitment of at least 823 new TAVI. The risk/propensity- adjustment techniques will be used to comparatively evaluate the effectiveness of TAVI vs AVR. Expected results. Safety and efficacy profiles of the new-generation TAVI prosthesis; comparative effectiveness of the new TAVI prosthesis as compared to TAVI procedures of the OBSERVANT historical cohort; comparative effectiveness of the new TAVI prosthesis as compared to AVR procedures of the OBSERVANT historical cohort. Conclusions. The results of OBSERVANT II will provide information on the effectiveness of TAVI employing new-generation devices and will be a valuable support to give professionals and policy makersevidence-based results useful for decision-making processes.

Original languageItalian
Pages (from-to)14S-26S
JournalGiornale Italiano di Cardiologia
Volume18
Issue number6
DOIs
Publication statusPublished - Jun 1 2017

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Aortic Valve Stenosis
Observational Studies
Equipment and Supplies
Aortic Valve
Therapeutics
Prostheses and Implants
Transcatheter Aortic Valve Replacement
Inventions
Risk Adjustment
Incidence
Hospital Mortality
Italy
Health Status
Comorbidity
Decision Making
Cohort Studies

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

OBSERVANT II : Studio osservazionale per la valutazione di efficacia delle procedure transcatetere con dispositivi di nuova generazione nel trattamento della stenosi aortica sintomatica severa. Protocollo di studio. / Seccareccia, Fulvia; Tarantini, Giuseppe; Bedogni, Francesco; Berti, Sergio; Santoro, Gennaro; Tamburino, Corrado; Ussia, Gian Paolo; Barbanti, Marco; Baiocchi, Massimo; Ranucci, Marco; D'Errigo, Paola; Rosato, Stefano; Musumeci, Giuseppe.

In: Giornale Italiano di Cardiologia, Vol. 18, No. 6, 01.06.2017, p. 14S-26S.

Research output: Contribution to journalArticle

Seccareccia, Fulvia ; Tarantini, Giuseppe ; Bedogni, Francesco ; Berti, Sergio ; Santoro, Gennaro ; Tamburino, Corrado ; Ussia, Gian Paolo ; Barbanti, Marco ; Baiocchi, Massimo ; Ranucci, Marco ; D'Errigo, Paola ; Rosato, Stefano ; Musumeci, Giuseppe. / OBSERVANT II : Studio osservazionale per la valutazione di efficacia delle procedure transcatetere con dispositivi di nuova generazione nel trattamento della stenosi aortica sintomatica severa. Protocollo di studio. In: Giornale Italiano di Cardiologia. 2017 ; Vol. 18, No. 6. pp. 14S-26S.
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abstract = "Background. The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study. Methods. OBSERVANT II is an observational multicenter, prospective, cohort study collecting data on patients with severe symptomatic aortic stenosis undergoing TAVI in Italian hospitals since December 15, 2016, for at least 12 months. For each patient, data on demographic characteristics, health status, type of intervention and presence of comorbidities will be collected. Mortality and incidence of in-hospital major adverse cardiac and cerebrovascular events (MACCE) within 36 months of intervention will be the primary adverse outcome. Secondary outcomes will include 30-day mortality and the incidence of MACCE at 12 and 24 months. The statistical hypotheses were formulated considering the results from the OBSERVANT study. Testing these hypotheses will require the recruitment of at least 823 new TAVI. The risk/propensity- adjustment techniques will be used to comparatively evaluate the effectiveness of TAVI vs AVR. Expected results. Safety and efficacy profiles of the new-generation TAVI prosthesis; comparative effectiveness of the new TAVI prosthesis as compared to TAVI procedures of the OBSERVANT historical cohort; comparative effectiveness of the new TAVI prosthesis as compared to AVR procedures of the OBSERVANT historical cohort. Conclusions. The results of OBSERVANT II will provide information on the effectiveness of TAVI employing new-generation devices and will be a valuable support to give professionals and policy makersevidence-based results useful for decision-making processes.",
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T2 - Studio osservazionale per la valutazione di efficacia delle procedure transcatetere con dispositivi di nuova generazione nel trattamento della stenosi aortica sintomatica severa. Protocollo di studio

AU - Seccareccia, Fulvia

AU - Tarantini, Giuseppe

AU - Bedogni, Francesco

AU - Berti, Sergio

AU - Santoro, Gennaro

AU - Tamburino, Corrado

AU - Ussia, Gian Paolo

AU - Barbanti, Marco

AU - Baiocchi, Massimo

AU - Ranucci, Marco

AU - D'Errigo, Paola

AU - Rosato, Stefano

AU - Musumeci, Giuseppe

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Background. The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study. Methods. OBSERVANT II is an observational multicenter, prospective, cohort study collecting data on patients with severe symptomatic aortic stenosis undergoing TAVI in Italian hospitals since December 15, 2016, for at least 12 months. For each patient, data on demographic characteristics, health status, type of intervention and presence of comorbidities will be collected. Mortality and incidence of in-hospital major adverse cardiac and cerebrovascular events (MACCE) within 36 months of intervention will be the primary adverse outcome. Secondary outcomes will include 30-day mortality and the incidence of MACCE at 12 and 24 months. The statistical hypotheses were formulated considering the results from the OBSERVANT study. Testing these hypotheses will require the recruitment of at least 823 new TAVI. The risk/propensity- adjustment techniques will be used to comparatively evaluate the effectiveness of TAVI vs AVR. Expected results. Safety and efficacy profiles of the new-generation TAVI prosthesis; comparative effectiveness of the new TAVI prosthesis as compared to TAVI procedures of the OBSERVANT historical cohort; comparative effectiveness of the new TAVI prosthesis as compared to AVR procedures of the OBSERVANT historical cohort. Conclusions. The results of OBSERVANT II will provide information on the effectiveness of TAVI employing new-generation devices and will be a valuable support to give professionals and policy makersevidence-based results useful for decision-making processes.

AB - Background. The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study. Methods. OBSERVANT II is an observational multicenter, prospective, cohort study collecting data on patients with severe symptomatic aortic stenosis undergoing TAVI in Italian hospitals since December 15, 2016, for at least 12 months. For each patient, data on demographic characteristics, health status, type of intervention and presence of comorbidities will be collected. Mortality and incidence of in-hospital major adverse cardiac and cerebrovascular events (MACCE) within 36 months of intervention will be the primary adverse outcome. Secondary outcomes will include 30-day mortality and the incidence of MACCE at 12 and 24 months. The statistical hypotheses were formulated considering the results from the OBSERVANT study. Testing these hypotheses will require the recruitment of at least 823 new TAVI. The risk/propensity- adjustment techniques will be used to comparatively evaluate the effectiveness of TAVI vs AVR. Expected results. Safety and efficacy profiles of the new-generation TAVI prosthesis; comparative effectiveness of the new TAVI prosthesis as compared to TAVI procedures of the OBSERVANT historical cohort; comparative effectiveness of the new TAVI prosthesis as compared to AVR procedures of the OBSERVANT historical cohort. Conclusions. The results of OBSERVANT II will provide information on the effectiveness of TAVI employing new-generation devices and will be a valuable support to give professionals and policy makersevidence-based results useful for decision-making processes.

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