Device success and 30-day clinical outcome in patients undergoing preimplant valvuloplasty in transfemoral versus omitting valvuloplasty in transapical transcatheter aortic valve replacement.

The study objective was to evaluate the impact of preimplantation balloon valvuloplasty on procedural outcomes in high-risk or no-option patients with aortic stenosis undergoing Edwards Lifesciences (Irvine, Calif) Sapien valve placement. Paravalvular aortic regurgitation has been associated with long-term mortality after transcatheter aortic valve replacement. Whether omitting preimplant balloon valvuloplasty affects paravalvular aortic regurgitation after Edwards Sapien transcatheter aortic valve replacement is currently unknown. We retrospectively analyzed the clinical outcome of 121 consecutive patients undergoing transapical (N = 50) or transfemoral (N = 71) Edwards Sapien transcatheter aortic valve replacement. Routinely, no preimplant balloon valvuloplasty was performed in transapical procedure as opposed to uniform preimplant balloon valvuloplasty in transfemoral cases. The incidence and severity of total and paravalvular aortic regurgitation and 30-day clinical outcomes were compared between the 2 cohorts. The average patient's age was 84.4 years, with a higher prevalence of smoking history (68% vs 42%, P = .005) and peripheral vascular disease (38% vs 20%, P = .03) in the patients undergoing transapical replacement. The preprocedural transthoracic echocardiographic and computed tomography findings were similar between the 2 cohorts. After transcatheter aortic valve replacement, the incidence of mild to moderate total aortic regurgitation (42% transfemoral vs 38% transapical), paravalvular aortic regurgitation (39% transfemoral vs 30% transapical), device success (88.7% transfemoral vs 94.0% transapical), and 30-day composite end points (9.9% transfemoral vs 14.0% transapical) were comparable in both groups. Multivariate regression analysis revealed male gender (odds ratio, 2.7; 95% confidence interval, 1.18-6.35; P = .02) but not preimplant balloon valvuloplasty as an independent predictor for mild or greater total aortic regurgitation. Compared with transapical transcatheter aortic valve replacement without preimplant balloon valvuloplasty, preimplant balloon valvuloplasty before transfemoral transcatheter aortic valve replacement resulted in a similar degree of prosthesis-related regurgitation, device success, and 30-day composite safety outcomes.

Wong SC ，Pawar S ，Minutello RM ，Horn EM ，Skubas NJ ，Devereux RB ，Salemi A ... -  《-》

Clinical outcome and paravalvular leakage of the new balloon-expandable Edwards Sapien 3 valve in comparison to its predecessor model (Edwards Sapien XT) in patients undergoing transfemoral aortic valve replacement.

The aim of this study was to compare the 30-day procedural, clinical and echocardiographic outcome of the new balloon-expandable Edwards Sapien 3 (ES3) valve with the Edwards Sapien XT (ESXT). Post-implant paravalvular leaks (PVL) after transfemoral aortic valve replacement (TAVR) resulting in residual aortic regurgitation (AR) are a major limitation for long term outcome. New TAVR-devices have to eliminate this problem. Transfemoral TAVR was performed in 209 consecutive intermediate-high-risk surgical patients (pts) with symptomatic aortic stenosis (ESXT n = 102, ES3 n = 107). Transthoracic echocardiography (TTE) and 3-dimensional computed tomography were used for valve size selection. Primary endpoint of the study was none/trace AR derived by TTE 30-days after TAVR. All pts underwent successfully TAVR with a combined device success of 100/102 (99%) in ESXT and 107/107 (100%) in ES3 pts. Fluoroscopy time (ESXT 11.8 ± 0.5 min vs. ES3 10.0 ± 0.5 min, P = 0.003) and contrast (ESXT 188.9 ± 5.6 mL vs. ES3 170.4 ± 4.7 mL, P = 0.04) were significantly lower in ES3 patients. 30-day clinical events did not differ. Transvalvular mean pressure gradients were significantly reduced to 7.4 ± 0.8 mmHg after ESXT and to 10.1± 0.4 mmHg after ES3 implantation. After 30 days none/trace AR was found in 34.3% (n = 35) of all ESXT pts in contrast to 89.7% (n = 96) of all ES3 patients. Moderate-to-severe AR was found rarely (ESXT 2.9% vs. ES3 0%, P = 0.073). Although there was no significant difference in 30 day mortality, the newer ES3 valve reduced significantly residual paravalvular leakage. © 2016 Wiley Periodicals, Inc.

Bocksch W ，Grossmann B ，Geisler T ，Steeg M ，Droppa M ，Jorbenadze R ，Haap M ，Gawaz M ，Fateh-Moghadam S ... -  《-》

Prosthesis-Specific Predictors of Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement: Impact of Calcification and Sizing on Balloon-Expandable versus Self-Expandable Transcatheter Heart Valves.

Stähli BE ，Nguyen-Kim TD ，Gebhard C ，Erhart L ，Frauenfelder T ，Tanner FC ，Falk V ，Landmesser U ，Nietlispach F ，Lüscher TF ，Maier W ，Binder RK ... -  《journal of heart valve disease》

Management of paravalvular regurgitation after Edwards SAPIEN transcatheter aortic valve replacement: management of paravalvular regurgitation after TAVR.

With the expansion in the use of transcatheter valve therapies for aortic stenosis, the incidence of hemodynamically significant paravalvular regurgitation (PVR) has become a clinical challenge. The study population consisted of those patients with either acute significant PVR immediately post-Edwards SAPIEN (ES) aortic valve implantation, requiring additional maneuvers during the index transcatheter aortic valve replacement (TAVR) or symptomatic PVR requiring treatment by transcatheter closure at a later date. All the patients were assessed within 24 hrs, 30 days, 3 months, 6 months and 12 months after the procedure. A total of 100 consecutive patients underwent ES TAVR (62% with 23 mm and 38% with 26 mm valve), of them 27% (27/100) were identified to have hemodynamically significant PVR requiring additional percutaneous interventions during or after the index procedure. Patient's mean age was 85 ± 12 years and 74% (20/27) were male. The mean Society of Thoracic Surgeon Score was 11.3% (range 4.6-17.6%), 59% had a 23 mm and 41% had a 26 mm ES valve. There was no difference in the occurrence of PVR between a) two valve sizes-23 mm (16/62) vs. 26 mm (11/38) (P = 0.817) and b) the two approaches-transfemoral (15/48) vs. transapical (TA) (12/52) (P = 0.37). A total of 32 procedures were performed on the 27 patients: one patient required four and two required two procedures each. There were 19 repeat ballooning, seven valve in valve and six transcatheter device closure procedures. The approach was retrograde in 66%, antegrade transeptal in 6% and antegrade TA in 28%. The procedural success rate was 90.6%, the total 30-day, 3 months and 6 months mortality rate was 7.4, 18.5, and 22% respectively. At the time of final analysis a total of 56% (15/27) had completed a 12 month follow-up. The management of PVR in the TAVR era is a technical challenge. We present our experience and propose a management approach.

Martinez CA ，Singh V ，O'Neill BP ，Alfonso CE ，Bilsker MS ，Martinez Clark P ，Williams D ，Cohen MG ，Heldman AW ，O'Neill WW ... -  《-》

Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve).

This study sought to characterize the patients receiving post-implantation balloon dilation (PD) following transcatheter aortic valve replacement (TAVR) and evaluate procedural outcomes in the PARTNER (Placement of Aortic Transcatheter Valve) I trial. Following TAVR, PD has been used to treat paravalvular regurgitation. The PARTNER I trial cohort A (n = 304) and cohort B (n = 194) patients randomized to TAVR and the nonrandomized continued access TAVR (n = 1,637) patients were included in the analysis. PD was performed at the discretion of the operator. Clinical events and echocardiographic variables were collected prospectively out to 1 year. The overall incidence of PD was 12.4%. PD patients had significantly less prosthesis-patient mismatch (p < 0.001) and larger effective orifice areas (p < 0.001) throughout the follow-up period. There were significantly more subacute strokes (occurring <7 days: 4.9% vs. 2.6%; p = 0.04) in PD patients but no difference in late stroke, either at 7 to 30 days (0.0% vs. 0.8%; p = 0.16) or >30 days (1.9 vs. 1.7%; p = 0.75). Although there was no significant increase in early mortality with PD, at 1 year, there was a trend for higher all-cause mortality (p = 0.054) and a significant difference in death or stroke (p = 0.04). When the subgroup of patients with none/trace paravalvular regurgitation were evaluated, there was no significant association of PD with mortality (p = 0.61) and death or stroke (p = 0.96). Multivariable analysis failed to show a relationship between PD and mortality. PD is associated with reduced rates of moderate or severe prosthesis-patient mismatch with no evidence for short-term structural deterioration of the balloon-expandable transcatheter valve. Although PD is associated with a greater incidence of early stroke, there is no significant association between PD and stroke beyond 7 days. Multivariable analysis shows no significant association between PD and mortality.

Hahn RT ，Pibarot P ，Webb J ，Rodes-Cabau J ，Herrmann HC ，Williams M ，Makkar R ，Szeto WY ，Main ML ，Thourani VH ，Tuzcu EM ，Kapadia S ，Akin J ，McAndrew T ，Xu K ，Leon MB ，Kodali SK ... -  《-》