Medium term outcomes of transapical aortic valve implantation: Results from the Italian registry of trans-apical aortic valve implantation

Augusto D'Onofrio, Stefano Salizzoni, Marco Agrifoglio, Linda Cota, Giampaolo Luzi, Paolo M. Tartara, Giovanni D. Cresce, Marco Aiello, Carlo Savini, Mauro Cassese, Alfredo Cerillo, Giuseppe Punta, Micaela Cioni, Davide Gabbieri, Chiara Zanchettin, Andrea Agostinelli, Enzo Mazzaro, Omar Di Gregorio, Giuseppe Gatti, Giuseppe FaggianClaudia Filippini, Mauro Rinaldi, Gino Gerosa

Research output: Contribution to journalArticle

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Abstract

Background: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). Methods: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). Results: Mean age was 81.0 ± 6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6% ± 16.3%, 9.4% ± 11.0%, and 10.6% ± 8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7% ± 1.5%, 76.1% ± 1.9%, and 67.6% ± 3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p = 0.04) but 3-year survival was not different (p = 0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p = 0.22). At discharge, peak and mean transprosthetic gradients were 21.0 ± 10.3 mm Hg and 10.2 ± 4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. Conclusions: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

Original languageEnglish
Pages (from-to)830-836
Number of pages7
JournalAnnals of Thoracic Surgery
Volume96
Issue number3
DOIs
Publication statusPublished - Sep 2013

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Aortic Valve
Registries
Mortality
Learning Curve
Survival
Aortic Valve Stenosis
Multicenter Studies
Hemodynamics
Therapeutics
Transcatheter Aortic Valve Replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

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Medium term outcomes of transapical aortic valve implantation : Results from the Italian registry of trans-apical aortic valve implantation. / D'Onofrio, Augusto; Salizzoni, Stefano; Agrifoglio, Marco; Cota, Linda; Luzi, Giampaolo; Tartara, Paolo M.; Cresce, Giovanni D.; Aiello, Marco; Savini, Carlo; Cassese, Mauro; Cerillo, Alfredo; Punta, Giuseppe; Cioni, Micaela; Gabbieri, Davide; Zanchettin, Chiara; Agostinelli, Andrea; Mazzaro, Enzo; Di Gregorio, Omar; Gatti, Giuseppe; Faggian, Giuseppe; Filippini, Claudia; Rinaldi, Mauro; Gerosa, Gino.

In: Annals of Thoracic Surgery, Vol. 96, No. 3, 09.2013, p. 830-836.

Research output: Contribution to journalArticle

D'Onofrio, A, Salizzoni, S, Agrifoglio, M, Cota, L, Luzi, G, Tartara, PM, Cresce, GD, Aiello, M, Savini, C, Cassese, M, Cerillo, A, Punta, G, Cioni, M, Gabbieri, D, Zanchettin, C, Agostinelli, A, Mazzaro, E, Di Gregorio, O, Gatti, G, Faggian, G, Filippini, C, Rinaldi, M & Gerosa, G 2013, 'Medium term outcomes of transapical aortic valve implantation: Results from the Italian registry of trans-apical aortic valve implantation', Annals of Thoracic Surgery, vol. 96, no. 3, pp. 830-836. https://doi.org/10.1016/j.athoracsur.2013.04.094
D'Onofrio, Augusto ; Salizzoni, Stefano ; Agrifoglio, Marco ; Cota, Linda ; Luzi, Giampaolo ; Tartara, Paolo M. ; Cresce, Giovanni D. ; Aiello, Marco ; Savini, Carlo ; Cassese, Mauro ; Cerillo, Alfredo ; Punta, Giuseppe ; Cioni, Micaela ; Gabbieri, Davide ; Zanchettin, Chiara ; Agostinelli, Andrea ; Mazzaro, Enzo ; Di Gregorio, Omar ; Gatti, Giuseppe ; Faggian, Giuseppe ; Filippini, Claudia ; Rinaldi, Mauro ; Gerosa, Gino. / Medium term outcomes of transapical aortic valve implantation : Results from the Italian registry of trans-apical aortic valve implantation. In: Annals of Thoracic Surgery. 2013 ; Vol. 96, No. 3. pp. 830-836.
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abstract = "Background: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). Methods: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50{\%} cases versus second 50{\%} cases of each center) and of the procedural volume (high-volume versus low-volume centers). Results: Mean age was 81.0 ± 6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6{\%} ± 16.3{\%}, 9.4{\%} ± 11.0{\%}, and 10.6{\%} ± 8.5{\%}, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9{\%} (77 patients). Overall 1-, 2-, and 3-year survival was 81.7{\%} ± 1.5{\%}, 76.1{\%} ± 1.9{\%}, and 67.6{\%} ± 3.2{\%}, respectively. Thirty-day mortality of the first 50{\%} patients of each center was higher when compared with the second half (p = 0.04) but 3-year survival was not different (p = 0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p = 0.22). At discharge, peak and mean transprosthetic gradients were 21.0 ± 10.3 mm Hg and 10.2 ± 4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. Conclusions: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.",
author = "Augusto D'Onofrio and Stefano Salizzoni and Marco Agrifoglio and Linda Cota and Giampaolo Luzi and Tartara, {Paolo M.} and Cresce, {Giovanni D.} and Marco Aiello and Carlo Savini and Mauro Cassese and Alfredo Cerillo and Giuseppe Punta and Micaela Cioni and Davide Gabbieri and Chiara Zanchettin and Andrea Agostinelli and Enzo Mazzaro and {Di Gregorio}, Omar and Giuseppe Gatti and Giuseppe Faggian and Claudia Filippini and Mauro Rinaldi and Gino Gerosa",
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TY - JOUR

T1 - Medium term outcomes of transapical aortic valve implantation

T2 - Results from the Italian registry of trans-apical aortic valve implantation

AU - D'Onofrio, Augusto

AU - Salizzoni, Stefano

AU - Agrifoglio, Marco

AU - Cota, Linda

AU - Luzi, Giampaolo

AU - Tartara, Paolo M.

AU - Cresce, Giovanni D.

AU - Aiello, Marco

AU - Savini, Carlo

AU - Cassese, Mauro

AU - Cerillo, Alfredo

AU - Punta, Giuseppe

AU - Cioni, Micaela

AU - Gabbieri, Davide

AU - Zanchettin, Chiara

AU - Agostinelli, Andrea

AU - Mazzaro, Enzo

AU - Di Gregorio, Omar

AU - Gatti, Giuseppe

AU - Faggian, Giuseppe

AU - Filippini, Claudia

AU - Rinaldi, Mauro

AU - Gerosa, Gino

PY - 2013/9

Y1 - 2013/9

N2 - Background: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). Methods: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). Results: Mean age was 81.0 ± 6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6% ± 16.3%, 9.4% ± 11.0%, and 10.6% ± 8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7% ± 1.5%, 76.1% ± 1.9%, and 67.6% ± 3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p = 0.04) but 3-year survival was not different (p = 0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p = 0.22). At discharge, peak and mean transprosthetic gradients were 21.0 ± 10.3 mm Hg and 10.2 ± 4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. Conclusions: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

AB - Background: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). Methods: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). Results: Mean age was 81.0 ± 6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6% ± 16.3%, 9.4% ± 11.0%, and 10.6% ± 8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7% ± 1.5%, 76.1% ± 1.9%, and 67.6% ± 3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p = 0.04) but 3-year survival was not different (p = 0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p = 0.22). At discharge, peak and mean transprosthetic gradients were 21.0 ± 10.3 mm Hg and 10.2 ± 4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. Conclusions: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

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