Sutureless aortic valve replacement as an alternative treatment for patients belonging to the "gray zone" between transcatheter aortic valve implantation and conventional surgery: a propensity-matched, multicenter analysis.

The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis. We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction. Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively (P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group (P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59). This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.

D'Onofrio A ，Messina A ，Lorusso R ，Alfieri OR ，Fusari M ，Rubino P ，Rinaldi M ，Di Bartolomeo R ，Glauber M ，Troise G ，Gerosa G ... -  《-》

Conventional surgery, sutureless valves, and transapical aortic valve replacement: what is the best option for patients with aortic valve stenosis? A multicenter, propensity-matched analysis.

Although surgical aortic valve replacement (SAVR) is the treatment of choice for patients with aortic valve stenosis, transcatheter aortic valve replacement (TAVR) and sutureless aortic valve replacement (SU-AVR) have shown good results. The aim of our multicenter, propensity-matched study was to compare the clinical and hemodynamic outcomes of surgical SAVR, transapical TAVR (TA-TAVR), and SU-AVR. We analyzed data from 566 TA-TAVR, 349 SAVR, and 38 SU-AVR patients treated from January 2009 to March 2012. We used a propensity-matching strategy to compare on-pump (SAVR, SU-AVR) and off-pump (TA-TAVR) surgical techniques. The outcomes were analyzed using multivariate weighted logistic regression or multinomial logistic analysis. In the matched cohorts, the 30-day overall mortality was significantly lower after SAVR than TA-TAVR (7% vs 1.8%, P = .026), with no differences in mortality between SU-AVR and TA-TAVR. Multivariate analysis showed SU-AVR to have a protective effect, although not statistically significant, against aortic regurgitation, pacemaker implantation, and renal replacement therapy compared with TA-TAVR. Compared with TA-TAVR, SAVR demonstrated significant protection against aortic regurgitation (odds ratio, 0.04; P < .001) and a trend toward protection against death, pacemaker implantation, and myocardial infarction. The mean transaortic gradient was 10.3 ± 4.4 mm Hg, 11 ± 3.4 mm Hg, and 16.5 ± 5.8 mm Hg in the TA-TAVR, SU-AVR, and SAVR patients, respectively. SAVR was associated with lower 30-day mortality than TA-TAVR. SAVR was also associated with a lower risk of postoperative aortic regurgitation compared with TA-TAVR. We did not find other significant differences in outcomes among matched patients treated with SAVR, SU-AVR, and TA-TAVR.

D'Onofrio A ，Rizzoli G ，Messina A ，Alfieri O ，Lorusso R ，Salizzoni S ，Glauber M ，Di Bartolomeo R ，Besola L ，Rinaldi M ，Troise G ，Gerosa G ... -  《-》

Effect of severe left ventricular systolic dysfunction on hospital outcome after transcatheter aortic valve implantation or surgical aortic valve replacement: results from a propensity-matched population of the Italian OBSERVANT multicenter study.

Despite demonstration of the superior outcomes of transcatheter aortic valve implantation (TAVI) versus optimal medical therapy for severe left ventricular systolic dysfunction, studies comparing TAVI and surgical aortic valve replacement (AVR) in this high-risk group have been lacking. We performed propensity matching for age, gender, baseline comorbidities, previous interventions, priority at hospital admission, frailty score, New York Heart Association class, EuroSCORE, and associated cardiac diseases. Next, the 30-day mortality and procedure-related morbidity of 162 patients (81 TAVI vs 81 AVR) with severe left ventricular systolic dysfunction (ejection fraction ≤ 35%) were analyzed at the Italian National Institute of Health. The 30-day mortality was comparable (P = .37) between the 2 groups. The incidence of periprocedural acute myocardial infarction (P = .55), low output state (P = .27), stroke (P = .36), and renal dysfunction (peak creatinine level, P = .57) was also similar between the 2 groups. TAVI resulted in significantly greater postprocedural permanent pacemaker implantation (P = .01) and AVR in more periprocedural transfusions (P < .01) despite a similar transfusion rate per patient (2.8 ± 3.7 for TAVI vs 4.4 ± 3.8 for AVR; P = .08). The postprocedural intensive care unit stay (median, 2 days after TAVI vs 3 days after AVR; P = .34), intermediate care unit stay (median, 0 days after both TAVI and AVR; P = .94), and hospitalization (median, 11 days after TAVI vs 14 days after AVR; P = .51) were comparable. In patients with severe left ventricular systolic dysfunction, both TAVI and AVR are valid treatment options, with comparable hospital mortality and periprocedural morbidity. Comparisons of the mid- to long-term outcomes are mandatory.

Onorati F ，D'Errigo P ，Grossi C ，Barbanti M ，Ranucci M ，Covello DR ，Rosato S ，Maraschini A ，Santoro G ，Tamburino C ，Seccareccia F ，Santini F ，Menicanti L ，OBSERVANT Research Group ... -  《-》

Sutureless replacement versus transcatheter valve implantation in aortic valve stenosis: a propensity-matched analysis of 2 strategies in high-risk patients.

This propensity-matched study compared clinical and echocardiographic outcomes between patients undergoing transcatheter aortic valve implantation (TAVI) and sutureless aortic valve replacement. From January 2010 to March 2012, 122 patients (age 79.4 ± 5.3 years, logistic euroSCORE 12% ± 8.4%) underwent minimally invasive sutureless aortic valve replacement, and 122 (age 84.6 ± 6.2 years, logistic euroSCORE 20.9% ± 2.5%) underwent TAVI. After propensity matching, 37 matched pairs were available for analysis. Preoperative characteristics and risk scores of matched groups were comparable. In-hospital mortalities were 0% in the sutureless group and 8.1% (n = 3) in the TAVI group (P = .24). Permanent pacemaker implantation was required in 4 patients in the sutureless group and 1 patient in the TAVI group (10.8% vs 2.7%; P = .18). A neurologic event was recorded in 2 patients of each group. Predischarge echocardiographic data showed higher paravalvular leak rate in the TAVI group (13.5% vs 0%; P = .027). At mean follow-up of 18.9 ± 10.1 months, overall cumulative survival was 91.9% and significantly differed between groups (sutureless 97.3% vs TAVI 86.5%; P = .015). In the TAVI group, a significant difference in mortality was observed between patients with (n = 20) and without (n = 17) paravalvular leak (25% vs 0%; P = .036). Combining the advantage of standard diseased valve removal with shorter procedural times, minimally invasive sutureless aortic valve replacement may be the first-line treatment for high-risk patients considered in the "gray zone" between TAVI and conventional surgery.

Santarpino G ，Pfeiffer S ，Jessl J ，Dell'Aquila AM ，Pollari F ，Pauschinger M ，Fischlein T ... -  《-》

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.

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. 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. 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). Female sex is a risk factor for mortality after aortic valve replacement, for major vascular complications after TAVI, and for transfusions after both approaches.

Onorati F ，D'Errigo P ，Barbanti M ，Rosato S ，Covello RD ，Maraschini A ，Ranucci M ，Santoro G ，Tamburino C ，Grossi C ，Santini F ，Menicanti L ，Seccareccia F ，OBSERVANT Research Group ... -  《-》