Acute and 30-Day Outcomes in Women After TAVR

Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry

Alaide Chieffo, A. Sonia Petronio, Julinda Mehilli, Jaya Chandrasekhar, S. Sartori, Thierry Lefèvre, Patrizia Presbitero, Piera Capranzano, Didier Tchetche, A. Iadanza, Gennaro Sardella, Nicolas M. van Mieghem, Emanuele Meliga, Nicolas Dumonteil, Chiara Fraccaro, Daniela Trabattoni, Ghada W. Mikhail, Samin Sharma, Maria Cruz Ferrer, Christoph Naber & 5 others Peter Kievit, Michela Faggioni, Clayton Snyder, Marie Claude Morice, Roxana Mehran

Research output: Contribution to journalArticle

Abstract

Objectives The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. Background Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. Methods The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Results Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7% and mean Society of Thoracic Surgeons score was 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. In more than two-thirds of cases, an Edwards SAPIEN 23 mm (Edwards Lifesciences, Irvine, California) or Medtronic CoreValve ≤26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0% with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. The independent predictors of the primary endpoint were age (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02; 95% CI: 1.07 to 3.80), left ventricular ejection fraction <30% (OR: 2.62; 95% CI: 1.07 to 6.40), new device generation (OR: 0.59; 95% CI: 0.38 to 0.91), and history of pregnancy (OR: 0.57; 95% CI: 0.37 to 0.85). Conclusions Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0% with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy.

Original languageEnglish
Pages (from-to)1589-1600
Number of pages12
JournalJACC: Cardiovascular Interventions
Volume9
Issue number15
DOIs
Publication statusPublished - Aug 8 2016

Fingerprint

Registries
Odds Ratio
Confidence Intervals
Stroke
Aortic Valve Stenosis
Safety
Research
Equipment and Supplies
Blood Vessels
Mortality
Hemorrhage
Reproductive History
Transcatheter Aortic Valve Replacement
Aortic Valve
Acute Kidney Injury
Surgical Instruments
Sex Characteristics
Stroke Volume
Coronary Vessels
Incidence

Keywords

  • early outcomes
  • first female registry
  • mortality
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Acute and 30-Day Outcomes in Women After TAVR : Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry. / Chieffo, Alaide; Petronio, A. Sonia; Mehilli, Julinda; Chandrasekhar, Jaya; Sartori, S.; Lefèvre, Thierry; Presbitero, Patrizia; Capranzano, Piera; Tchetche, Didier; Iadanza, A.; Sardella, Gennaro; van Mieghem, Nicolas M.; Meliga, Emanuele; Dumonteil, Nicolas; Fraccaro, Chiara; Trabattoni, Daniela; Mikhail, Ghada W.; Sharma, Samin; Ferrer, Maria Cruz; Naber, Christoph; Kievit, Peter; Faggioni, Michela; Snyder, Clayton; Morice, Marie Claude; Mehran, Roxana.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 15, 08.08.2016, p. 1589-1600.

Research output: Contribution to journalArticle

Chieffo, A, Petronio, AS, Mehilli, J, Chandrasekhar, J, Sartori, S, Lefèvre, T, Presbitero, P, Capranzano, P, Tchetche, D, Iadanza, A, Sardella, G, van Mieghem, NM, Meliga, E, Dumonteil, N, Fraccaro, C, Trabattoni, D, Mikhail, GW, Sharma, S, Ferrer, MC, Naber, C, Kievit, P, Faggioni, M, Snyder, C, Morice, MC & Mehran, R 2016, 'Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry', JACC: Cardiovascular Interventions, vol. 9, no. 15, pp. 1589-1600. https://doi.org/10.1016/j.jcin.2016.05.015
Chieffo, Alaide ; Petronio, A. Sonia ; Mehilli, Julinda ; Chandrasekhar, Jaya ; Sartori, S. ; Lefèvre, Thierry ; Presbitero, Patrizia ; Capranzano, Piera ; Tchetche, Didier ; Iadanza, A. ; Sardella, Gennaro ; van Mieghem, Nicolas M. ; Meliga, Emanuele ; Dumonteil, Nicolas ; Fraccaro, Chiara ; Trabattoni, Daniela ; Mikhail, Ghada W. ; Sharma, Samin ; Ferrer, Maria Cruz ; Naber, Christoph ; Kievit, Peter ; Faggioni, Michela ; Snyder, Clayton ; Morice, Marie Claude ; Mehran, Roxana. / Acute and 30-Day Outcomes in Women After TAVR : Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 15. pp. 1589-1600.
@article{7cd752b4dae24ccfabfa63f4ea413547,
title = "Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry",
abstract = "Objectives The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. Background Although women comprise 50{\%} of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. Methods The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Results Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7{\%} and mean Society of Thoracic Surgeons score was 8.3 ± 7.4{\%}. TAVR was performed via transfemoral access in 90.6{\%} and new-generation devices were used in 42.1{\%}. In more than two-thirds of cases, an Edwards SAPIEN 23 mm (Edwards Lifesciences, Irvine, California) or Medtronic CoreValve ≤26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0{\%} with 3.4{\%} all-cause mortality, 1.3{\%} stroke, 7.7{\%} major vascular complications, and 4.4{\%} VARC life-threatening bleeding. The independent predictors of the primary endpoint were age (odds ratio [OR]: 1.04; 95{\%} confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02; 95{\%} CI: 1.07 to 3.80), left ventricular ejection fraction <30{\%} (OR: 2.62; 95{\%} CI: 1.07 to 6.40), new device generation (OR: 0.59; 95{\%} CI: 0.38 to 0.91), and history of pregnancy (OR: 0.57; 95{\%} CI: 0.37 to 0.85). Conclusions Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0{\%} with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy.",
keywords = "early outcomes, first female registry, mortality, transcatheter aortic valve replacement",
author = "Alaide Chieffo and Petronio, {A. Sonia} and Julinda Mehilli and Jaya Chandrasekhar and S. Sartori and Thierry Lef{\`e}vre and Patrizia Presbitero and Piera Capranzano and Didier Tchetche and A. Iadanza and Gennaro Sardella and {van Mieghem}, {Nicolas M.} and Emanuele Meliga and Nicolas Dumonteil and Chiara Fraccaro and Daniela Trabattoni and Mikhail, {Ghada W.} and Samin Sharma and Ferrer, {Maria Cruz} and Christoph Naber and Peter Kievit and Michela Faggioni and Clayton Snyder and Morice, {Marie Claude} and Roxana Mehran",
year = "2016",
month = "8",
day = "8",
doi = "10.1016/j.jcin.2016.05.015",
language = "English",
volume = "9",
pages = "1589--1600",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "15",

}

TY - JOUR

T1 - Acute and 30-Day Outcomes in Women After TAVR

T2 - Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry

AU - Chieffo, Alaide

AU - Petronio, A. Sonia

AU - Mehilli, Julinda

AU - Chandrasekhar, Jaya

AU - Sartori, S.

AU - Lefèvre, Thierry

AU - Presbitero, Patrizia

AU - Capranzano, Piera

AU - Tchetche, Didier

AU - Iadanza, A.

AU - Sardella, Gennaro

AU - van Mieghem, Nicolas M.

AU - Meliga, Emanuele

AU - Dumonteil, Nicolas

AU - Fraccaro, Chiara

AU - Trabattoni, Daniela

AU - Mikhail, Ghada W.

AU - Sharma, Samin

AU - Ferrer, Maria Cruz

AU - Naber, Christoph

AU - Kievit, Peter

AU - Faggioni, Michela

AU - Snyder, Clayton

AU - Morice, Marie Claude

AU - Mehran, Roxana

PY - 2016/8/8

Y1 - 2016/8/8

N2 - Objectives The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. Background Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. Methods The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Results Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7% and mean Society of Thoracic Surgeons score was 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. In more than two-thirds of cases, an Edwards SAPIEN 23 mm (Edwards Lifesciences, Irvine, California) or Medtronic CoreValve ≤26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0% with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. The independent predictors of the primary endpoint were age (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02; 95% CI: 1.07 to 3.80), left ventricular ejection fraction <30% (OR: 2.62; 95% CI: 1.07 to 6.40), new device generation (OR: 0.59; 95% CI: 0.38 to 0.91), and history of pregnancy (OR: 0.57; 95% CI: 0.37 to 0.85). Conclusions Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0% with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy.

AB - Objectives The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. Background Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. Methods The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Results Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7% and mean Society of Thoracic Surgeons score was 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. In more than two-thirds of cases, an Edwards SAPIEN 23 mm (Edwards Lifesciences, Irvine, California) or Medtronic CoreValve ≤26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0% with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. The independent predictors of the primary endpoint were age (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02; 95% CI: 1.07 to 3.80), left ventricular ejection fraction <30% (OR: 2.62; 95% CI: 1.07 to 6.40), new device generation (OR: 0.59; 95% CI: 0.38 to 0.91), and history of pregnancy (OR: 0.57; 95% CI: 0.37 to 0.85). Conclusions Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0% with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy.

KW - early outcomes

KW - first female registry

KW - mortality

KW - transcatheter aortic valve replacement

UR - http://www.scopus.com/inward/record.url?scp=84991756908&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84991756908&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2016.05.015

DO - 10.1016/j.jcin.2016.05.015

M3 - Article

VL - 9

SP - 1589

EP - 1600

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 15

ER -