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 ... -  《-》

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 ... -  《-》

Surgical sutureless and transcatheter aortic valves: hemodynamic performance and clinical outcomes in propensity score-matched high-risk populations with severe aortic stenosis.

In propensity score-matched patients with severe aortic stenosis treated with surgical aortic valve replacement (AVR) with the 3f Enable sutureless prosthesis (Medtronic, Minneapolis, Minnesota) or transcatheter aortic valve replacement (TAVR), the hemodynamic performance of both valves and mid-term survival of patients were evaluated. Data on hemodynamic performance of surgical sutureless bioprostheses in high operative risk patients with aortic stenosis are scarce. Of 258 patients undergoing TAVR or surgical aortic valve replacement with the 3f Enable valve, 80 (79 ± 5 years of age, 100% men) were included in the current analysis on the basis of propensity score 1:1 matching for baseline clinical and hemodynamic characteristics. All patients had hemodynamic echocardiographic evaluation at baseline and discharge. Mid-term survival was analyzed. Compared with the 3f Enable valve, TAVR prostheses (Edwards SAPIEN XT [Edwards Lifesciences, Irvine, California] and CoreValve [Medtronic]) had larger effective orifice area index (1.00 ± 0.30 cm(2)/m(2) vs. 0.76 ± 0.22 cm(2)/m(2); p < 0.001), lower pressure gradient (8.14 ± 4.21 mm Hg vs. 10.72 ± 4.01 mm Hg; p = 0.006), less frequent prosthesis-patient mismatch (30.0% vs. 67.5%; p = 0.001), and low flow (46.2% vs. 72.5%; p = 0.02), but more frequent aortic regurgitation (87.5% vs. 20.0%; p < 0.001). The presence of prosthesis-patient mismatch was independently associated with a low-flow state at discharge (odds ratio: 4.70; p = 0.004) and independently associated with the use of the sutureless prosthesis (odds ratio: 3.90; p = 0.02). However, the survival of the 2 groups was comparable after 1.5-year (interquartile range: 0.79 to 2.01 years) follow-up (log-rank test, p = 0.95). TAVR prostheses demonstrated better hemodynamics than the 3f Enable valve but a higher incidence of aortic regurgitation. However, these differences did not influence mid-term survival of patients.

Kamperidis V ，van Rosendael PJ ，de Weger A ，Katsanos S ，Regeer M ，van der Kley F ，Mertens B ，Sianos G ，Ajmone Marsan N ，Bax JJ ，Delgado V ... -  《-》

Treating the patients in the 'grey-zone' with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement.

Although the use of transcatheter aortic valve replacement (TAVR) has recently become an attractive strategy in extremely high-risk patients undergoing aortic valve replacement (AVR), the most appropriate treatment option in patients with an intermediate- to high-risk profile with conventional surgery (sAVR), TAVR or novel options, such as sutureless valves, has been widely debated. One hundred and sixty-three consecutive patients with intermediate to high risk were prospectively enrolled and selected to undergo sAVR (Group 1: G1, n = 55), sutureless valve implantation (Group 2: G2, n = 53) or TAVR (Group 3: G3, n = 55) following a multidisciplinary evaluation including frailty, anatomy and degree of atherosclerotic disease of the aorta/peripheral vessels. The mean logistic EuroSCORE (G1 = 21.3 ± 12.7 vs G2 = 16 ± 11.7 vs G3 = 20.4 ± 12.7, P = 0.06) and preoperative demographics, such as age, gender and left ventricular ejection fraction, were similar: of note, chronic obstructive pulmonary disease was more frequent in TAVI patients (G1 = 27.2% vs G2 = 15.1% vs G3 = 47%; P <0.01). The Perceval S sutureless valve was used in Group 2, whereas TAVR was performed with a Corevalve prosthesis. Post-procedural pacemaker implantation (G1 = 1.8% vs G2 = 2% vs G3 = 25.5%, P <0.001) and peripheral vascular complications (G1 = 0% vs G2 = 0% vs G3 = 14.5%, P <0.001) occurred more frequently in patients undergoing TAVR. Hospital mortality was similar among the groups (G1 = 0% vs G2 = 0% vs G3 = 1.8%, P = NS). At the 24-month follow-up, overall survival free from major adverse cardiac and cerebrovascular events and prosthetic regurgitation was better in patients who had undergone sAVR and sutureless valves than those who had undergone TAVR (G1 = 95.2 ± 3.3% vs G2 = 91.6 ± 3.8% vs G3 = 70.5 ± 7.6%; P = 0.015). This preliminary study suggests that the use of TAVR in patients with an intermediate- to high-risk profile is associated with a higher rate of perioperative complications and decreased survival at the 24-month follow-up compared with the use of conventional surgery or sutureless valves.

Muneretto C ，Bisleri G ，Moggi A ，Di Bacco L ，Tespili M ，Repossini A ，Rambaldini M ... -  《-》

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 ... -  《-》