Hemodynamic performance and outcome of percutaneous versus surgical stentless bioprostheses for aortic stenosis with anticipated patient-prosthesis mismatch.

We aimed to compare the performance and midterm survival of transcutaneous aortic valve replacement (TAVR) and surgically implanted stentless aortic valve replacement (SAVR) for severe aortic stenosis in patients anticipated to have patient-prosthesis mismatch (PPM). A retrospective analysis was performed of 86 and 49 consecutive TAVR and SAVR patients with severe aortic stenosis and calculated minimal effective orifice area larger than the best projected effective orifice area. Cox hazard analyses were used to assess the effect of TAVR versus SAVR on outcome. The peak and mean transprosthetic gradient at discharge were lower (P < .001 for both) in the TAVR group. Mild or greater aortic regurgitation was more frequent in the TAVR group (61% vs 7%; P < .0001). At 3 months of follow-up, the mean gradient in the TAVR group was similar to that of the SAVR group but the prevalence of aortic regurgitation was still higher. The unadjusted 3-year survival rate was superior in the SAVR versus TAVR group (91.6% ± 4% vs 67.0% ± 7%; P = .01). Adjustments for both age and comorbidity resulted in loss of the difference in mortality between the 2 groups. In patients with anticipated PPM, TAVR offers an immediate lower incidence of PPM than SAVR but a greater prevalence of aortic regurgitation. The differences in transaortic gradients became nonsignificant 3 months postoperatively. The question of whether TAVR is a suitable substitute for SAVR in patients with anticipated PPM, in particular, those who are older and sicker, warrants additional investigation.

Finkelstein A ，Schwartz AL ，Uretzky G ，Banai S ，Keren G ，Kramer A ，Topilsky Y ... -  《-》

Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis.

We compared the incidence of prosthesis-patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm(2)/m(2)) and no severe PPM (EOAi > 0.65 cm(2)/m(2)); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group (P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% [P = .0145] for death and 19.2% vs 8.5% [P = .0008] for acute kidney injury). In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.

Zorn GL 3rd ，Little SH ，Tadros P ，Deeb GM ，Gleason TG ，Heiser J ，Kleiman NS ，Oh JK ，Popma JJ ，Adams D ，Huang J ，Reardon MJ ... -  《-》

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 ... -  《-》

Clinical profile and outcome of patients with severe aortic stenosis at high surgical risk: single-center prospective evaluation according to treatment assignment.

The study sought to assess the clinical profile, outcome, and predictors for mortality of "real-world" high-risk severe aortic stenosis patients according to the mode of treatment assigned. Patients were referred to a dedicated clinic for meticulous screening and multidisciplinary team assessment and 343 were finally assigned treatment (age 81.3 ± 7.2 years, 42.3% men): transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN or CoreValve device, 100 (29.2%); surgical aortic valve replacement (SAVR), 61 (17.8%); balloon valvuloplasty (as definitive therapy), 27 (7.9%); medication only, 155 (45.2%). No patient was lost to follow-up. The balloon valvuloplasty group had a significantly higher 1-month mortality rate (18.5%) than the TAVR group (3%, P = 0.006) and medical therapy group (3.9%; P = 0.004), without significant difference from the SAVR group (11.5%, P = 0.5). One-year cumulative survival was significantly higher in the TAVR group (92%) than in the other groups (SAVR 71%, balloon valvuloplasty 61.5%, medication 65%; all P < 0.001). Among survivors, 1-year rates of high functional class (NYHA I/II) were as follows: TAVR, 84.6%; SAVR, 63.3%; balloon valvuloplasty, 18.2%; medication, 21.4% (TAVR vs. SAVR, P = 0.04; SAVR vs. balloon valvuloplasty or medical therapy, P = 0.01). On multivariate regression analysis, renal failure (hazard ratio [HR] = 5.3, P < 0.001), not performing TAVR (HR = 4.9, P < 0.001), and pulmonary pressure (10 mm Hg, HR = 1.2, P = 0.02) were independent predictors of 1-year mortality. TAVR, performed in carefully selected high-risk patients, is associated with an excellent survival rate and high functional class. Patients treated with another of the available modalities, including SAVR, had a worse outcome, regardless of which alternative treatment they receive.

Dvir D ，Sagie A ，Porat E ，Assali A ，Shapira Y ，Vaknin-Assa H ，Shafir G ，Bental T ，Nevzorov R ，Battler A ，Kornowski R ... -  《-》

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 ... -  《-》