Comparison of the Hemodynamic Performance of the Balloon-expandable SAPIEN 3 Versus Self-expandable Evolut R Transcatheter Valve: A Case-matched Study

Enríquez-Rodríguez, Eduardo; Amat‐Santos, Ignacio J.; Jiménez‐Quevedo, Pilar; Martin-Morquecho, Irene; Tirado‐Conte, Gabriela; Pérez-Vizcayno, Marı́a José; Diego, José Juan Gómez de; Arnold, Román; Aldazábal, Andrés; Rojas, Paol; Agustin, José Alberto de; Trigo, María Del; Gutiérrez, Hipólito; Román, José Alberto San; Macaya, Carlos; Nombela‐Franco, Luis

doi:10.1016/j.rec.2017.10.025

Cited by 18 publications

(26 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Evolut R device has already shown to yield a higher rate of PPI in Evolut R U.S. study (16.4%) compared to those reported by SAPIEN 3 and ACURATE neo devices in PARTNER 2 study and SAVI‐TF registry (10.1 and 8.3%, respectively). Recently, Enriquez‐Rodriguez et al confirmed a higher risk of PPI using Evolut R compared to SAPIEN 3 device (19 vs. 7.5%, respectively, p = .04), whereas Husser et al demonstrated a higher risk of PPI for patients undergoing TAVI with SAPIEN 3 compared to ACURATE neo device (15.5 vs. 9.9%, respectively, p = .02) . Our propensity‐matched analysis confirmed a significant difference in PPI rate among TAV‐groups, with a higher incidence in patients receiving Evolut R, an intermediate incidence in patients receiving SAPIEN 3 and a very low incidence in patients treated with ACURATE neo TAV (16.7 vs. 8.3 vs. 2.1%, respectively, p < .05).…”

Section: Discussionsupporting

confidence: 68%

“…2 Some studies have already reported a comparison between second generation balloon-expandable SAPIEN 3 and self-expandable Evolut R, or ACURATE neo TAVs, demonstrating comparable procedural and 30-day outcomes. 7,8 In our study, we reported high device success and composite safety endpoint rates for all the devices with lower, although not sig- First, the intra-annular position of SAPIEN 3 valve's leaflets conditions an increased friction among leaflets themselves compared to supra-annular valves, where the prosthetic leaflets are not forced into the native anatomical annular zone. This standing leads to an increased turbulence and greater sheer stress of blood flow, contributing to raise transvalvular gradients.…”

Section: Discussionmentioning

confidence: 60%

“…In a recent meta‐analysis, we reported a marked reduction in all‐cause and cardiovascular death (from 7.8 and 2.2% to 4.1 and 1.6%, respectively), life‐threatening bleeding, and major vascular complications (from 15.6 and 11.9 to 3.9 and 4.5%, respectively) as well as in disabling stroke rate (from 3.2 to 0.9%) of TAVI using new‐generation devices compared to first generation devices . Some studies have already reported a comparison between second generation balloon‐expandable SAPIEN 3 and self‐expandable Evolut R, or ACURATE neo TAVs, demonstrating comparable procedural and 30‐day outcomes …”

Section: Discussionmentioning

confidence: 96%

“…With the expanding of devices market and the wider experience of operators, more and more centers are now using different types of TAVs, taking advantages from the different features of each devices to fit properly each anatomical situation. To date, few studies have reported a head‐to‐head comparison among the new devices available on the market . To our knowledge, this is the first matched comparison among the three most widely used TAVI devices—Edwards SAPIEN 3, Medtronic Evolut R, and Boston ACURATE neo.…”

Section: Discussionmentioning

confidence: 97%

“…At 30‐day echocardiographic assessment, in two different studies SAPIEN 3 valve previously reported in higher mean transvalvular gradient (11 ± 7 vs. 7 ± 3 and 12 ± 5 vs. 8 ± 4 mmHg, p < .01 and p < .01, respectively) and lower more‐than‐mild paravalvular regurgitation (PVR) rates (2.5 vs. 9.4% and 1.8 vs. 4.8%, respectively) compared to Evolut R and ACURATE neo devices …”

Section: Discussionmentioning

confidence: 99%

See 4 more Smart Citations

Outcomes of three different new generation transcatheter aortic valve prostheses

Costa

Buccheri

Barbanti

et al. 2019

Cathet Cardio Intervent

View full text Add to dashboard Cite

Aims To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF‐TAVI) using three different new‐generation devices. Background Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head‐to‐head comparisons are available among these devices. Methods This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF‐TAVI for native, severe aortic stenosis using a new‐generation transcatheter aortic valve (TAV) with a preprocedural multi‐detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method. RESULTS The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30‐day all‐cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p < .05). At 30 days, patients treated with SAPIEN 3 valve showed a higher mean transvalvular gradient (9.7 ± 7.5 mmHg vs. 6.1 ± 2.4 mmHg vs. 8.4 ± 3.5 mmHg for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01) and a lower rate of more‐than‐trace paravalvular regurgitation (PVR) (18.8 vs. 47.9 vs. 45.8%, for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01). At 1 year, SAPIEN 3, Evolut R, and ACURATE neo TAVs showed excellent and comparable outcomes with no difference in terms of freedom from major adverse cardiovascular and cerebrovascular event (MACCE) (plog‐rank = 0.534). Conclusions TAVI using new‐generation prostheses was associated with high device success (97.0% vs. 92.8% vs. 95.0% for SAPIEN 3, Evolut R and ACURATE neo, respectively) and low complications rates up to 1 year. Evolut R valve was associated with a higher rate of PPI whereas SAPIEN 3 valve was associated with a higher mean transvalvular gradient and lower rate of more‐than‐trace PVR. At 1‐year, MACCE rates were similar among the three groups.

show abstract

Section: Discussionsupporting

confidence: 68%

Section: Discussionmentioning

confidence: 60%

Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Outcomes of three different new generation transcatheter aortic valve prostheses

Costa

Buccheri

Barbanti

et al. 2019

Cathet Cardio Intervent

View full text Add to dashboard Cite

show abstract

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

Hase

Yoshijima

Yanagisawa

et al. 2020

Cathet Cardio Intervent

View full text Add to dashboard Cite

Objectives To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self‐expanding and balloon‐expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. Background Few studies have directly compared TAVR outcomes using third‐generation THVs, focusing on patients with small aortic annuli. Methods In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third‐generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. Results The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0–11.9] vs. 12.0 [IQR: 9.9–16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01–1.46] vs. 1.08 [IQR: 0.90–1.28] cm2/m2, p < .001}. However, no significant differences were reported in the incidence of severe prosthesis‐patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all‐cause mortality (log‐lank test, p = .81). Conclusions TAVR for patients with a small annulus using third‐generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all‐cause mortality at 1 year was similar between both groups.

show abstract

Aortic Regurgitation After Transcatheter Aortic Valve Implantation

Borz¹

2019

Transcatheter Aortic Valve Implantation

View full text Add to dashboard Cite

Comparison of the Hemodynamic Performance of the Balloon-expandable SAPIEN 3 Versus Self-expandable Evolut R Transcatheter Valve: A Case-matched Study

Cited by 18 publications

References 31 publications

Outcomes of three different new generation transcatheter aortic valve prostheses

Outcomes of three different new generation transcatheter aortic valve prostheses

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

Aortic Regurgitation After Transcatheter Aortic Valve Implantation

Contact Info

Product

Resources

About