1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement: Results from the Italian OBSERVANT study

Corrado Tamburino, Marco Barbanti, Paola D'Errigo, Marco Ranucci, Francesco Onorati, Remo Daniel Covello, Francesco Santini, Stefano Rosato, Gennaro Santoro, Danilo Fusco, Claudio Grossi, Fulvia Seccareccia

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120 Citations (Scopus)

Abstract

Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. Methods The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.

Original languageEnglish
Pages (from-to)804-812
Number of pages9
JournalJournal of the American College of Cardiology
Volume66
Issue number7
DOIs
Publication statusPublished - Aug 18 2015

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Aortic Valve
Surgical Instruments
Propensity Score
Aortic Valve Stenosis
Cause of Death
Confidence Intervals
Population
Mortality
Multicenter Studies
Observational Studies
Transcatheter Aortic Valve Replacement
Cohort Studies
Heart Failure
Databases
Incidence

Keywords

  • aortic stenosis
  • implantation
  • intermediate risk
  • transcatheter aortic valve

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement : Results from the Italian OBSERVANT study. / Tamburino, Corrado; Barbanti, Marco; D'Errigo, Paola; Ranucci, Marco; Onorati, Francesco; Covello, Remo Daniel; Santini, Francesco; Rosato, Stefano; Santoro, Gennaro; Fusco, Danilo; Grossi, Claudio; Seccareccia, Fulvia.

In: Journal of the American College of Cardiology, Vol. 66, No. 7, 18.08.2015, p. 804-812.

Research output: Contribution to journalArticle

Tamburino, C, Barbanti, M, D'Errigo, P, Ranucci, M, Onorati, F, Covello, RD, Santini, F, Rosato, S, Santoro, G, Fusco, D, Grossi, C & Seccareccia, F 2015, '1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement: Results from the Italian OBSERVANT study', Journal of the American College of Cardiology, vol. 66, no. 7, pp. 804-812. https://doi.org/10.1016/j.jacc.2015.06.013
Tamburino, Corrado ; Barbanti, Marco ; D'Errigo, Paola ; Ranucci, Marco ; Onorati, Francesco ; Covello, Remo Daniel ; Santini, Francesco ; Rosato, Stefano ; Santoro, Gennaro ; Fusco, Danilo ; Grossi, Claudio ; Seccareccia, Fulvia. / 1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement : Results from the Italian OBSERVANT study. In: Journal of the American College of Cardiology. 2015 ; Vol. 66, No. 7. pp. 804-812.
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abstract = "Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. Methods The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2{\%} vs. 9.5 ± 7.1{\%}, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6{\%} in the surgical group and 13.8{\%} in the transcatheter group (hazard ratio [HR]: 0.99; 95{\%} confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6{\%} in the surgical group and 18.2{\%} in the transcatheter group (HR: 1.03; 95{\%} CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.",
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T2 - Results from the Italian OBSERVANT study

AU - Tamburino, Corrado

AU - Barbanti, Marco

AU - D'Errigo, Paola

AU - Ranucci, Marco

AU - Onorati, Francesco

AU - Covello, Remo Daniel

AU - Santini, Francesco

AU - Rosato, Stefano

AU - Santoro, Gennaro

AU - Fusco, Danilo

AU - Grossi, Claudio

AU - Seccareccia, Fulvia

PY - 2015/8/18

Y1 - 2015/8/18

N2 - Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. Methods The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.

AB - Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. Methods The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.

KW - aortic stenosis

KW - implantation

KW - intermediate risk

KW - transcatheter aortic valve

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