Different impact of sex on baseline characteristics and major periprocedural outcomes of transcatheter and surgical aortic valve interventions: results of the multicenter Italian OBSERVANT Registry

Background: Despite the widespread use of transcatheter aortic valve implantation (TAVI), the role of sex on outcome after TAVI or surgical aortic valve replacement (AVR) has been poorly investigated. We investigated the impact of sex on outcome after TAVI or AVR. Methods: There were 2108 patients undergoing TAVI or AVR who were enrolled in the Italian Observational Multicenter Registry (OBSERVANT). Thirty-day mortality, major periprocedural morbidity, and transprosthetic gradients were stratified by sex according to interventions. Results: Female AVR patients showed a worse risk profile compared with male AVR patients, given the higher mean age, prevalence of frailty score of 2 or higher, New York Heart Association class of 3 or higher, lower body weight, and preoperative hemoglobin level (P ≤.02). Similarly, female TAVI patients had a different risk profile than male TAVI patients, given a higher age and a lower body weight and preoperative hemoglobin level (P ≤.005), but with a similar New York Heart Association class, frailty score, EuroSCORE (P = NS), a better left ventricular ejection fraction and a lower prevalence of left ventricular ejection fraction less than 30%, porcelain aorta, renal dysfunction, chronic obstructive pulmonary disease, arteriopathy, and previous cardiovascular surgery or percutaneous coronary intervention (P ≤.01). Women showed a smaller aortic annulus than men in both populations (P <.001). Female sex was an independent predictor in the AVR population for risk-Adjusted 30-day mortality (odds ratio [OR], 2.34; P =.043) and transfusions (OR, 1.47; P =.003), but not for risk-Adjusted acute myocardial infarction, stroke, vascular complications, permanent atrioventricular block (P = NS). Female sex was an independent predictor in the TAVI population for risk-Adjusted major vascular complications (OR, 2.92; P =.018) and transfusions (OR, 1.93; P =.003), but proved protective against moderate to severe postprocedural aortic insufficiency (P =.018). Conclusions: Female sex is a risk factor for mortality after aortic valve replacement, for major vascular complications after TAVI, and for transfusions after both approaches. Copyright © 2014 by The American Association for Thoracic Surgery

1-Year Outcomes After Transfemoral Transcatheter or Surgical Aortic Valve Replacement: Results From the Italian OBSERVANT Study.

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; OBSERVANT Research Group. Collaborators (209) Marra S, Marra S, D'Amico M, Gaita F, Moretti C, De Benedictis M, Aranzulla T, Pistis G, Reale M, Bedogni F, Brambilla N, Ferrario M, Ferrero L, Vicinelli P, Colombo A, Chieffo A, Ferrari A, Inglese L, Casilli F, Ettori F, Frontini M, Antona C, Piccaluga E, Klugmann S, De Marco F, Tespili M, Saino A, Leonzi O, Rizzi A, Grisolia E, Franceschini Grisolia E, Isabella G, Fraccaro C, Bernardi G, Bisceglia T, Armellini I, Vischi M, Parodi E, Vignali L, Ardissimo D, Marzocchi A, Marrozzini C, Cremonesi A, Colombo F, Giannini C, Pierli C, Iadanza A, Santoro G, Meucci F, Berti S, Mariani M, Tomai F, Ghini A, Violini R, Confessore P, Crea F, Giubilato S, Sardella G, Mancone M, Ribichini F, Vassanelli C, Dandale R, Giudice P, Vigorito F, Liso A, Specchia L, Indolfi C, Spaccarotella C, Stabile A, Gandolfo C, Tamburino C, Ussia G, Comoglio C, Dyrda O, Rinaldi M, Salizzoni S, Micalizzi E, Grossi C, Di Gregorio O, Scoti P, Costa R, Casabona R, Del Ponte S, Panisi P, Spira G, Troise G, Messina A, Viganò M, Aiello M, Alfieri O, Denti P, Menicanti L, Agnelli B, Donatelli F, Muneretto C, Frontini M, Rambaldini M, Frontini M, Gamba A, Tasca G, Ferrazzi P, Terzi A, Antona C, Gelpi G, Martinelli L, Bruschi G, Graffigna AC, Mazzucco A, Pappalardo A, Gatti G, Livi U, Pompei E, Coppola R, Gucciardo M, Parodi E, Albertini A, Caprili L, Ghidoni I, Gabbieri D, La Marra M, Aquino T, Gherli T, Policlinico S, Di Bartolomeo R, Savini C, Popoff G, Innocenti D, Bortolotti U, Pratali S, Stefano P, Blanzola C, Glauber M, Cerillo A, Chiaramonti F, Pardini A, Fioriello F, Torracca L, Rescigno G, De Paulis R, Nardella S, Musumeci F, Luzi G, Possati G, Bonalumi G, Covino E, Pollari F, Sinatra R, Roscitano A, Chiariello L, Nardi P, Lonobile T, Baldascino F, Di Benedetto G, Mastrogiovanni G, Piazza L, Marmo J, Vosa C, De Amicis V, Speziale G, Visicchio G, Spirito R, Gregorini R, Specchia L, Villani M, Pano MA, Bortone A, De Luca Tupputi Schinosa L, De Cillis E, Gaeta R, Di Natale M, Cassese M, Antonazzo A, Argano V, Santaniello E, Patanè L, Gentile M, Tribastone S, Follis F, Montalbano G, Pilato M, Stringi V, Patanè F, Salamone G, Ruvolo G, Pisano C, Mignosa C, Bivona A, Cirio EM, Lixi G, Seccareccia F, D'Errigo P, Rosato S, Maraschini A, Badoni G, Tamburino C, Santoro G, Santini F, Grossi C, Ranucci M, Covello RD, Fusco D, Onorato F, De Palma R, Scandotto S, Orlando A, Copello F, Borgia P, Marchetta F, Porcu R. 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 trial

1-Year Outcomes After Transfemoral Transcatheter or Surgical Aortic Valve Replacement: Results From the Italian OBSERVANT Study.

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